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 Table of Contents  
ORIGINAL RESEARCH
Year : 2022  |  Volume : 14  |  Issue : 4  |  Page : 394-402

Validity and reliability of Impact on Family Scale for Indonesian cleft lip and palate parents: A questionnaire-based study


Department of Oral and Maxillofacial Surgery, Faculty of Dental Medicine and Academic Dental Hospital, Universitas Airlangga, East Java, Indonesia

Date of Submission20-Aug-2021
Date of Decision29-Apr-2022
Date of Acceptance29-Apr-2022
Date of Web Publication29-Aug-2022

Correspondence Address:
Dr, Andra Rizqiawan
Jl. Major General Prof. Dr. Moestopo, No. 47, Surabaya 60132, East Java
Indonesia
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JIOH.JIOH_220_21

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  Abstract 

Aim: Cleft lip and palate (CLP) in children might impact their parents’ mental health. The pathology may cause burden in the parents’ life, primarily in the financial and social aspects. The IOFS (Impact on Family Scale) questionnaire, with 33 items and 4 aspects, measures the quality of life by quantifying the impact on families of chronic childhood conditions. This cross-sectional study was conducted to assess the validity and reliability of the IOFS. Materials and Methods: The translation of the IOFS questionnaire to Indonesian language was conducted by two translators. Thirty respondents based in three regions in East Nusa Tenggara (Kupang, Bima, and Selong) were selected for data collection. The scoring was measured using a Likert scale, and then the data were tested by Pearson’s bivariate test and Cronbach’s alpha test to assess the questionnaire’s validity and reliability, respectively. Results: A total of 31 statements showed validity scaling using the coefficient Pearson’s correlation >0.361 (P < 0.05) and 29 statements showed reliable scaling (Cronbach’s alpha) >0.60 (P < 0.05). The overall validity and reliability test revealed 27 valid and reliable IOFS instrument statements. Conclusion: The majority of the statements were valid and reliable. Thus, the IOFS instrument can be considered a reliable, valid, and straightforward tool to assess the burden on the cleft and lip palate family in Indonesia.

Keywords: Children Well-Being Index, Cleft Lip–Palate, Family, Quality of Life, Validity and Reliability


How to cite this article:
Al Fessi R, Rizqiawan A, Kamadjaja DB. Validity and reliability of Impact on Family Scale for Indonesian cleft lip and palate parents: A questionnaire-based study. J Int Oral Health 2022;14:394-402

How to cite this URL:
Al Fessi R, Rizqiawan A, Kamadjaja DB. Validity and reliability of Impact on Family Scale for Indonesian cleft lip and palate parents: A questionnaire-based study. J Int Oral Health [serial online] 2022 [cited 2022 Oct 5];14:394-402. Available from: https://www.jioh.org/text.asp?2022/14/4/394/355015


  Introduction Top


Children’s lives not only depend on physical health aspects but also the family situation, psychological condition, and social environment. Various aspects that affect children’s lives also affect their well-being. The children well-being index consists of a multidimensional combination among mental or psychological, physical health, and social dimensions.[1] One multidimensional aspect that affects physical health is the teeth and mouth condition. Cleft lip and palate children have the potential to develop some issues with their teeth and mouth. If cleft lip and palate condition is not treated, it can interfere with masticatory, speech, and aesthetics. In addition, if the nutritional intake is insufficient, it will affect the child’s psychological and physical condition. Physically, facial appearance is related to self-confidence. Appearance satisfaction is a component of mental health that plays an essential role in social interaction. Thus, cleft lip and palate can affect children’s quality of life.[2]

Most studies investigated only on physical consequences of an event. The condition of children with cleft lip and palate can affect the family situation and most likely reduce the quality of life in children.[3],[4] It is also reported as one of the factors that may cause parents’ anxiety about children with cleft lip and palate. This issue mainly occurs in Africa, where local beliefs and cultures contribute to psychosocial instability and infant mortality.[5]

The study aims to analyze parents’ burden in caring for their children with cleft, such as psychological and economic burdens. Changes in appearance can affect a family’s ability to cope and adapt and the bonding relationship between parent and child. Nurturing children with a cleft has a high impact on psychological stress to their caregivers because of expenses, time, and emotional factors and thus could subsequently cause the children to be neglected and not receive adequate treatment.[6] The delay in handling may be due to parents’ and their families’ physical and psychological burdens.[7]

The impact on the parents and caregivers from nurturing children with a cleft is primarily financial and social. Because of that, an instrument to assess the effect of psychological matters on parents could be helpful to reduce the delayed treatment of cleft lip and palate cases. The financial and social impacts of the significant effect on families and caregivers result from the activities of caring for children with cleft lip and palate.[8] Therefore, an assessment instrument is needed to detect psychological problems in parents to reduce the number of delays in handling cleft lip and palate cases.

Cleft lip and palate, in developed countries, causes morbidity in children associated with a considerable financial risk for the family, along with the increase of burden that occurs in society.[9] Most families were found to have a psychological impact after discovering that their child was born with cleft lip and palate.[10] Aspects of psychological impact are anxiety, depression, and the inability to cope with the circumstance.[9],[10] Nusa Tenggara is one of the provinces presumed to have a high incidence of orofacial cleft (OFC) in Indonesia. Data distributions showed that OFC in Nusa Tenggara was 8.60%, above the national incidence of 2.40%.[11] It is interesting to investigate the impact of life expectancy on cleft lip and palate families analytically. Therefore, this research adopted the Impact on Family Scale (IOFS) instrument for the population in rural areas such as Nusa Tenggara, Indonesia.

The financial and social impact is the most significant impact of caring for children with cleft lip and palate children.[8],[9] Several problems lead to delayed treatment for cleft lip and palate children, including lack of knowledge about medical providers, feeding problems, lack of emotional support, difficulty finding financial support, parental neglect, and the problem related to anomaly.[12],[13],[14] The delay in handling may be due to parents’ and their families’ physical and psychological burdens.[15]

Previous studies obtained measurements of the impact on families and caregivers from caring for cleft lip and palate children using a scale IOFS. IOFS is a questionnaire to detect the subjective quality felt by the family. The IOFS scores were generally higher in all the dimensions of life in the OFC caregiver group than in the non-OFC group.[16] The instrument has been used in several countries such as Thailand, France, Turkey, Nigeria.

In Thailand, the instrument can measure the socio-economic impact on families using 24 reliable statements (Cronbach’s alpha value >0.7). Five aspects of IOFS were reduced to only three aspects: namely, financial aspects, social aspects, and personal aspects.[17] In France, a similar study was conducted using the scale IOFS, and the instrument was declared valid and reliable, and the highest score was obtained for the impact of parental adaptation on coping with problems. From the two studies, there is a process of reducing the statement.[18] The highest score was obtained for the pattern of adaptation of parents in problem-solving.

In Turkey, the instrument having as many as 19 valid and reliable statements has been used. The highest impact is obtained on family relationships to the social environment. Cleft lip and palate mothers had higher mean parenting stress scores than the control mothers.[19] The study also stated that the concept of “roller-coaster” did not provide an appropriate meaning to describe the feelings of the Turkish people.[19] This strengthens the reason for the study and the statement “roller-coaster” needs to be replaced with the term “complex emotional feelings.” Emotional feelings while caring for a child with chronic illness are mentioned in the literature.[20] In Nigeria, the study of the adaptation of the IOFS instrument used four of the five aspects of IOFS.[21] Moreover, the study found the same high impact on financial aspects similar to this study.

The instrument IOFS has been carried out in various languages but has not yet been adapted into Indonesian language. This study was carried out by translating and adapting the instrument IOFS to assess the validity and reliability of the instrument IOFS in families with cleft lip and palate in Indonesia.


  Ethical policy and Institutional Review Board statement Top


Ethical approval was obtained from the Health Research Ethical Clearance Commission at the Faculty of Dental Medicine, Universitas Airlangga, with registry number 063/HRECC.FODM/II/2020/The impact of children with non-syndromic cleft lip and palate on the family’s life on February 28, 2020.


  Materials and Methods Top


Setting and design

Type of study

The design of this research is an adaptation study of the questionnaire method.

Location, duration, and recruitment

The population of this study was the parent of cleft lip and palate patients which is aged 0-5 years who had undergone their first surgery by the Cleft Lip and Palate Team of the Dental Hospital, Universitas Airlangga, during community service activities conducted in Kupang Regency, Bima Regency, and Selong Regency, Nusa Tenggara, Indonesia on January 2018– December 2019.

Data collection

Researchers collected data by filling out IOFS questionnaires to detect emotional impacts on family life. The questionnaires have been translated into Indonesian and filled in by 30 respondents by telephone. The respondents were 30 parents whose children had undergone cleft lip and palate surgery up to 3 months after surgery [Table 1]. Data collection was carried out on the 30 parents or caregivers of patients. Data on the distribution of respondents by age range jobs are mentioned in [Table 2].
Table 1: Age distribution and cases of cleft lip and palate

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Table 2: Respondent distribution data according to type of case, age, and occupation of parents or nanny

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The proportion of patients with a cleft lip was higher than those with a cleft palate. In terms of the age distribution of the patient’s parents and caregivers, most caregivers are 30–39 years old. In terms of occupation, most of the parents of sufferers are self-employed. All of the respondents’ children had undergone surgery and had been controlled to remove the sutures. The time to fill out the questionnaire was up to 6 months after surgery, during the postoperative control. The results of this research questionnaire were tested using the SPSS (25.0. IBM Corp., Armonk, NY, USA) statistical application with the test coefficients Pearson and Cronbach’s alpha, which can present the results of the validity and reliability of the research questionnaire answers directly.

Questionnaire method

Scoring was done using 4-point Likert scale, namely, 1: disagree very much; 2: disagree; 3: agree; 4: agree very much.

Observational parameters

  1. The independent variable is the respondent filling in the questionnaire. Respondent matches with inclusion criteria: parents of a patient with lip and cleft palate age 0–5 years old and never received any surgery before.


  2. Dependent variable: validity and reliability from the IOFS questionnaire.


  3. Cases type: lip cleft type (unilateral, bilateral, complete, incomplete) and palate cleft type (unilateral, bilateral, complete, incomplete).


  4. Child’s age: 0–5 years old. Subjects of the age of 5 years are supposed to complete the treatment.


  5. Parent’s age: the age of a patient’s parents with a cleft.


  6. Patient’s gender: gender of the patient with cleft.


  7. Financial impact: fee that has to be paid for treatment and support associated with a patient with a cleft.


  8. Social impact: environment circumstance that has to be faced by parents of a patient with a cleft.


  9. Personal impact: personal feeling experienced by parents of a patient with a cleft.


  10. Coping strategy: the way parents overcome the situation.


  11. Impact on siblings: the presence of a chronically ill family member may adversely affect the psychological health of siblings.


Sampling criteria

  1. Willingly to participate in research.


  2. Patients with cleft lip and palate Community Service Program from January 2018 to December 2019.


  3. Patients aged 0–5 years old with lip and cleft palate who never received any surgery or treatment before;


  4. The general condition is still considered normal with a birth weight minimum of 2500 g, without any congenital syndrome, and currently not receiving therapy like the patient with special needs and autism.


Validity

Validity testing was used to measure whether the questionnaire items were valid or not. Validity level was measured by using Cronbach’s alpha which can present validity test results and reliability answers directly. One questionnaire statement point is valid when the corrected item-total correlation is more significant than the r-value of the table. This study uses a significance level of 95%, and the n-value was 30. R-table was 28 that was decided by a total of respondents minus two. Thus r-table value was 0.361. If r-value > r table product-moment, then the questionnaire is valid.

Reliability

Measurement of reliability was carried out using a one-shot measure.[22] Measurement of instrument grain reliability was done with a single scatter questionnaire to respondents, and the results of the scores were measured for the correlation between score answers on the same question item with the help of a computer SPSS (25.0., IBM Corp.), with Cronbach’s alpha (a). If the Cronbach’s alpha value for a constructor variable is more than 0.60, it is deemed to be reliable.

Statistical analysis

The numbers of respondents were assigned using the Slovin formula. The Slovin formula is a respondent determination formula used for a definite population.[23] In a population of 85 families with children with lip and cleft palate, the calculation of the number of respondents is as follows:



The n is the minimum respondent size, N is the population size, e the set margin of error is 0.05. Then the population size is:





This study estimates the sample size using the power calculation (Clincalc online calculator):



Parameters: p0 was the proportion (incidence) of the population which was 8.60%, p1 was the proportion (incidence) of the study group which was 30%, N was the sample size for the study group, α was the probability of type I error (0.05), β was the probability of type II error (0.10), z was critical Z-value for a given α or β. Power was 1−β (0.90) to detect the difference between groups. The Clincalc online calculator was used and the minimum number of respondents in this study was 28, rounded up to 30.

In this study, the IOFS instrument was adopted and performed on 30 children with cleft and lip palate; this follows the statement of Johansen et al. about the “Pilot Test,” which was the first step of experimental research to adapt a new instrument with a minimum of 30 respondents.[22],[24] The sample variables in this study were: (1) case type: type of cleft lip (unilateral, bilateral, complete, and incomplete) and type of cleft palate (unilateral, bilateral, complete, and incomplete), (2) child’s age, (3) parents’ age, and (4) parents’ occupation. The type of data in this study was secondary data, namely, patient medical records who participated in the social service activities in Indonesia. This research’s methodology and analysis process are shown in [Figure 1].
Figure 1: Methodology and analysis process

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For the beginning step, validity and reliability tests for the instrument were done as a beginning study as a pilot test to adapt a new instrument with 30 respondents. A validity test was completed to assess whether the statement of the questionnaire could be measured accurately. The validity coefficient was assessed from product–moment correlation Pearson in SPSS Programme (25.0. IBM Corp.).


  Results Top


From descriptive data distribution of 30 patients, the result was as follows: male patient respondents as much as 46.7%, female patient respondents as much as 53.30%, age distribution 0–1 year old 53.30%, 1–2 years old 23.30%, 2–3 years old 6.70%, 3–4 years old 13.30%, and 4–5 years old 3.30%.

The primary diagnosis was labioschizis 63.30% and palatoschizis 36.70%. The incidence rate for labioschizis in females is 0 and that in males is 14. The incidence rate for palatoschizis in females is 11and that in males is 0. Additional diagnosis cases such as gnatoschizis were 16.70% of all cases. Cases with health comorbidities such as anemia were 20% of all the cases. Distribution age of parents or caregivers was 20–29 years old 33.30%, 30–39 years old 46.70%, 40–49 years old 20%, and the majority of caregivers were father or grandfather, as much as 76.70%.

The correlation between parameters was analyzed using Spearman; there were several parameters that have significant correlation [df = 29 and confidence interval (CI)= 95%]; there were main diagnosis and age with a significant correlation of 0.001 (<0.05) main diagnosis and additional diagnosis with a significant correlation of 0.047 (<0.05).

However, there are several parameters that have no significant correlation (df = 29 and CI = 95%); they were main diagnosis and health comorbidities with no significant correlation 0.334 (>0.05) and main diagnosis and gender with no significant correlation 0.667 (>0.05). The data showed that health comorbidities revealed no predisposition to main diagnosis with an odds ratio of 0.328 (>0.33). There was no gender predisposition to the primary diagnosis with an odds ratio of 0.654 (>0.33).

The qualitative data analysis had been done using the MANOVA (multivariate analysis of variance) test to analyze the association among gender, age, additional diagnosis, and health comorbidities. Compared with the primary diagnosis, the result was significant (0.000) with power analysis (1.00).

[Table 3] showed that from 33 questionnaire statement points, 31 statement points meet the validity test. In comparison, the other 2 points of the statement are not valid. Reliability test using Cronbach’s Alpha is shown in [Table 4]. On reliability, if we testify the value of >0.6, then it was considered reliable.
Table 3: Validity test result

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Table 4: Reliability test results

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The reliability test table showed that from 33 statement points, as many as 29 statement points met the reliability test, whereas the remaining 4 statements were not reliable. The valid questionnaire keyword was 31 points, whereas the reliable statement was 29 points. In this study, no parents or caregivers suffered from cleft lip and palate, nor were they currently undergoing any medical therapy, so it did not affect the interpretation of their child’s condition. There are four statements from the financial aspect of the questionnaire. The results obtained by Cronbach’s alpha have an average of 0.798 (Cronbach’s alpha value >0.60), which showed that the four statement points for the financial aspect are reliable. From the social aspect, it was known that there were 15 statements. The results obtained by Cronbach’s alpha had an average of 0.882 (Cronbach’s alpha value >0.60), so it could be said that the 15 points of the questionnaire statement for the social aspect were reliable. There were five statements from the personal aspect. The results obtained by Cronbach’s alpha had an average of 0.848 (Cronbach’s alpha value >0.60), so it showed that the five statements for the personal aspect were reliable.

From the aspect of coping with the problem, it was known that there were three statements. The results obtained by Cronbach’s alpha had an average of 0.887 (Cronbach’s alpha value >0.60), so it could be concluded that the three statements for coping with the problem aspect are reliable. From the sibling aspect, it was known that there were six statements, the average Cronbach’s alpha results were 0.590 (Cronbach’s alpha value >0.60), so it could be concluded that the six statements for the sibling’s aspect were not reliable, even though two of them were reliable.


  Discussion Top


In this study, the IOFS instrument was adapted and performed on 30 families taking care of their children with cleft lip and palate; this is following the statement of Johanson et al. about the “Pilot Test,” which is a preliminary study to adapt a new instrument with 30 respondents.[23],[24] The instrument has been widely adopted and applied in other countries such as Thailand, France, Turkey, and Nigeria but has never been adopted in Indonesia.[2],[17],[18],[19]

For the beginning step, validity and reliability tests for the instrument were done as a beginning study as a pilot test to adapt a new instrument with 30 respondents. A validity test was completed to assess whether the statement of the questionnaire could be accurately measured. The validity coefficient was assessed from product–moment correlation Pearson in SPSS Programme (25.0, IBM Corp.). A reliability test was done to show how far the test from this instrument can be reliable. Validity and reliability tests were applied in numeric data with a Likert scale, interval, or ratio.[25] Scoring was carried out from the 33 questionnaires with the distribution of values (degree of freedom 29, mean difference, 95% CI of the difference with lower and upper values) attached to [Table 5].
Table 5: Value of questionnaires

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In the invalid questionnaire, statements such as “My life is up and down, sad when my child’s condition is bad, happy when my child is healthy” and “sometimes I feel like we live on a roller coaster” did not represent an appropriate meaning for the population in Nusa Tenggara. Bek et al.’s[26] study showed that in Turkey by also replacing “My life is up and down....” and the statement “sometimes I feel like we live on a roller coaster...” phrases with another descriptor convey the same meaning because it does not give an appropriate meaning to describe the feelings of the Turkish people. These statements have been replaced by the term “complex emotional journey,” which goes up decreased according to the reference to the care of children with chronic diseases.[27]

Another invalid statement is “I have to stop working because my child is sick.” This statement is invalid because most respondents still work even though they have a sick child. Most of the respondents are self-employed and can manage working time and time to take care of their children. This statement is not following with the previous study concept. Namely, parents need to take leave from work when taking the patient to the hospital.[2],[4],[7],[28]

The reliability test results were obtained four inconsistent statements: statements about the child’s relationship with the neighborhood, relationship sibling health, sibling social relations, and relationships with his parent. This is sufficient to represent the respondent’s attitude against children with cleft lip and palate. The social environment was not differentiating between children with chronic conditions and those with apparently healthy conditions. There is no impact on siblings and their kindship relations, which causes conflict in the family.[29]

From the 33 IOFS questionnaire statements, there are 31 valid statements and 29 reliable statements. It can be concluded that the IOFS instrument applies to the population in Nusa Tenggara, Indonesia. Later, this instrument should be adapted to a nationwide population. The overall validity and reliability test results obtained 31 valid and reliable statements, representing four aspects: financial impact, social impact, personality, and problem-solving skills.[22]

The unreliable IOFS questionnaire statement, which is a sibling aspect, was not used in the research instrument because of no impact on the sibling’s relationship as the sociodemographic condition in Nusa Tenggara was different from that abroad. In the future, another more suitable adaptation method can be used.[29]

From the overall validity and reliability test results, 27 valid and reliable IOFS instrument statements were obtained, representing four aspects: financial impact, social impact, personal impact, and problem-solving ability. Those four aspects represent the impact analysis and proper IOFS instrument adaptation study.[2],[7],[10],[27]

Limitations

The limitation of this study is a limited number of respondents because other respondents live in remote areas that have limited access to communication. Another limitation is that the data collection was obtained by telephone, thus could create misinterpretation between the respondents and the researcher. Interviewees via telephone could not interpret non-verbal expressions such as concealing their emotions.


  Conclusion Top


Validity and reliability of the financial impact were social, personal, and problem-solving abilities. The questionnaire contained 33 statements, with 27 being valid and reliable statements. The IOFS instrument can be determined to be valid and reliable for adaptation and application to the Indonesian population. Socio-economic conditions in Indonesia are different from those in other countries. As a result, the instrument’s validity and reliability tests varied from one region to another. Indonesian families can benefit from devices that measure the cleft lip and palate effect on families.

Acknowledgements

The research was supported by the Faculty of Dental Medicine and Dental Hospital, Universitas Airlangga, Surabaya, Indonesia.

Financial support and sponsorship

Nil.

Conflicts of interest

There is no conflict of interest in this study.

Authors’ contribution

AR: conceptualization, methodology, writing––review and editing. DBK: supervision, review and editing. RAF: writing initial draft preparation, visualization, investigation, writing, reviewing, and editing. All the authors approved the final version of the article for publication.

Ethical policy and Institutional Review Board statement

Ethical approval was obtained from the Health Research Ethical Clearance Commission at the Faculty of Dental Medicine, Universitas Airlangga, with registry number 063/HRECC. FODM/II/2020/ The impact of children with non-syndromic cleft lip and palate on the family’s life on February 28, 2020.

Declaration of patient consent

Participants were explained clearly about the study purpose and a written informed consent was obtained before conducting the study.

Data availability statement

Not applicable.

 
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    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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Abstract
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Ethical policy a...
Materials and Me...
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