This study was a quasi-experimental design with a pretest-posttest control group, conducted to examine the effect of music therapy on sleep quality in children aged 4 - 12 years with autism spectrum disorder. The study population included all eligible children aged 4 - 12 years with ASD who were referred to autism centers in Lahore, Pakistan, in 2026. The sample size was calculated using the following formula: n = (Nz²pq) / (Nd² + z²pq). z is the standard normal deviate corresponding to a 95% confidence level (z = 1.96), p is the estimated proportion of the attribute (p = 0.5), q = 1 − p (q = 0.5), and d is the margin of error (d = 0.05). Based on this calculation, the final sample size was estimated to be 80 participants.
A total of 80 eligible children were recruited using a convenience sampling method. After confirming eligibility, participants were assigned to either the intervention group (n = 40) or the control group (n = 40) using a simple lottery method. Specifically, equal numbers of cards labeled intervention and control were placed in a container, and each participant drew one card to determine group assignment. The allocation process was conducted by a research assistant who was not involved in outcome assessment. Due to the nature of the study design, allocation concealment was not feasible; however, assignment was performed only after enrollment to minimize selection bias. Baseline characteristics of the two groups were compared to assess their initial comparability.
Inclusion criteria were a confirmed diagnosis of autism for at least one year based on medical records, presence of sleep disturbances as determined by the score on the Children’s Sleep Habits Questionnaire, ability to understand and follow simple instructions, and absence of conditions such as blindness or deafness. Exclusion criteria included unwillingness to continue participation or the emergence of new physical or psychological problems during the study period.
Of the 80 eligible children, all were assigned to the intervention group (n = 40) or control group (n = 40). No participants withdrew or were excluded after allocation during the intervention, post-test, or follow-up assessments. Therefore, the analyzed sample was identical to the enrolled sample at all stages.
Data were collected using a demographic questionnaire (age, birth order, gender, mother’s age, father’s age, mother’s education, father’s education, mother’s occupation, father’s occupation, and number of children in the family) and the Children’s Sleep Habits Questionnaire developed by Owens, Spirito, and colleagues (2000). This questionnaire contains 33 items scored on a 3-point Likert scale, with total scores ranging from 33 to 99.
Content validity was reviewed by 10 experts in nursing, pediatrics, and psychology, and their recommendations were incorporated. Face validity was assessed by 12 parents of children to ensure that the items were understandable, and necessary adjustments were made. The reliability of the questionnaire was calculated using Cronbach’s alpha, yielding a coefficient of 0.88. The validity and reliability of this questionnaire have been confirmed in multiple studies conducted in Iran.
The study procedure involved parents completing the Children’s Sleep Habits Questionnaire for both the intervention and control groups before the intervention. In the intervention group, three instrumental music pieces were used: Beethoven’s Piano Sonata No. 14 in C-sharp minor, Op. 27 (Moonlight), 1st Movement, performed by Daniel Barenboim; Claude Debussy’s “Clair de Lune,” performed by Maria Pierre; and Arvo Pärt’s “Spiegel im Spiegel,” performed by Jürgen Kreuz (piano) and Benjamin Hudson (viola). These pieces were chosen for their calming and relaxing effects on children and were approved by a musician and music instructor.
The three selected pieces were played each night, in the specified order, for 20 consecutive nights, 30 minutes before the child’s bedtime, by the parents in the child’s bedroom at a low volume. One parent remained present in the room during this time. The researcher provided the music files to parents via mobile phone. Parents were trained by the researcher to play the music 30 minutes before bedtime, placing the phone approximately 30 cm from the child, setting the volume to a moderate level to avoid discomfort, enabling airplane mode to prevent interruptions, controlling the room lighting to ensure comfort, and minimizing external noises so the child’s attention would focus solely on the music. Each child in the intervention group listened to a total of 437 minutes and 20 seconds of the three music pieces over the course of the intervention.
Adherence was monitored through daily parental logs, which were reviewed by the research team at each session. All children completed the intended number of sessions; missed sessions, if any, were rescheduled within the study period. Intervention fidelity was ensured by providing parents with standardized instructions, and a research assistant periodically observed sessions to confirm correct implementation. This monitoring ensured that the planned intervention dose was consistently delivered across participants.
The control group received no intervention during this period but continued their routine occupational therapy as previously conducted. After the intervention and one month later (for follow-up), the Children’s Sleep Habits Questionnaire was completed again for both groups.
Both the intervention and control groups continued to receive routine occupational therapy and other standard care as prescribed by their treating clinics. The frequency, duration, and type of these background therapies were monitored and recorded for both groups to ensure comparability. No additional therapies beyond the usual care were introduced for either group during the study period. This approach minimized potential confounding by co-interventions and ensured that observed effects could be attributed to the music therapy intervention.
Statistical analyses were conducted using Statistical Package for the Social Sciences (SPSS) version 26. Paired t-tests were used to assess within-group changes from pre- to post-intervention. Independent t-tests were applied to compare groups at each time point. To control for baseline differences, ANCOVA was employed for the primary outcome (post-intervention sleep quality), with baseline scores as covariates. Assumptions of normality and homogeneity of variance were checked using Shapiro-Wilk and Levene’s tests, respectively. Repeated measures over follow-up were analyzed as secondary outcomes to evaluate the persistence of intervention effects. A significance level of P < 0.05 was applied for all tests.
This study protocol was assessed and approved by the Institutional Research Ethics Board of the University of Lahore (UOL/IREB/26/17/03/06). Prior to the study, the research objectives were explained to parents, and written informed consent was obtained. Participation was entirely voluntary, and participants could withdraw at any stage without any negative consequences. Parents were assured that children’s personal information and responses would remain confidential and used solely for research purposes.