The Impact of a Comfort Theory-Based Infant Sleep Hygiene Training Program on Infant Sleep Habits and Parental Self-Efficacy
Phase: NA
Conditions: Sleep Hygiene, Infant Sleeping Habits, Parent Education, Self Efficacy
Sponsor: Karabuk University

Infant Sleep Hygiene Education Program RCT – Protocol / Statistical Analysis Plan 
NCT Number: NCTXXXXXXX 
Document Date: 06.10.2025 
1. Study Title 
The Impact of a Comfort Theory-Based Infant Sleep Hygiene Training Program on Infant 
Sleep Habits and Parental Self-Efficacy 
 
2. Background 
Sleep is a vital physiological function that significantly impacts children's physical, cognitive, 
motor, and emotional development (Hudson et al., 2020). A healthy sleep pattern is essential 
for children's growth, development, and overall well-being (El-Sheikh & Kelly, 2017). Sleep, 
a key driver of brain development (de Goot et al., 2024), has positive effects on memory, 
language, executive functions, and overall cognitive development (Tham et al., 2017; 
Hernandez-Reif & Gungordu, 2022). On the other hand, sleep problems experienced in early 
childhood have been associated with developmental delays in neurocognitive, social-
emotional, and physical health areas, as well as impairments in family functioning (Hysing et 
al., 2016). 
Sleep habits change rapidly during early childhood, and individual differences can be 
observed (Tham et al., 2017). Although sleep duration problems generally decrease with age, 
the most intense sleep problems and nighttime awakenings occur particularly during infancy 
(Williamson et al., 2019; Oras et al., 2020). Nighttime awakenings are common during the 
first year, with infants under 1 year of age waking up an average of 2-3 times per night (Oras 
et al., 2020). When the infant is unable to calm themselves and fall back asleep after these 
awakenings, parents may perceive this as a sleep problem (Hiscock & Davey, 2018). 
Sleep problems experienced during infancy are a significant source of stress for parents and 
can negatively affect the mother-infant relationship (Ophoff et al., 2018; Tikotzky, 2016; 
Vertsberger et al., 2020). While some parents view sleep regulation as a developmental goal 
(Sviggum et al., 2018), others have less confidence in their instincts and feel the need for 
professional guidance (Hsu et al., 2017; Cook et al., 2020). Furthermore, how parents 
perceive their infant's sleep is closely related to their self-efficacy levels; high self-efficacy 
may lead to perceiving sleep problems as less problematic (Cato et al., 2024; Werner et al., 
2022). Therefore, educating and supporting parents on infant sleep is of great importance for 
both child and family health (Vieira, et al., 2020; Basınlı & Kahraman, 2018). Research 
shows that educational programs for parents contribute to infants developing healthy sleep 
habits, increasing nighttime sleep duration, and improving self-regulation skills related to 
falling asleep and staying asleep (McDowall et al., 2017; Basınlı & Kahraman, 2018; 
Svavarsdottir et al., 2025). Therefore, well-designed and implemented educational programs 
can prevent sleep problems in infants or reduce existing problems (Basınlı & Kahraman, 
2018; Svavarsdottir et al., 2025). 
 
Although various infant sleep interventions exist, many are heterogeneous in content and 
intensity, and some behaviorally oriented approaches raise ethical and developmental 

concerns due to potential negative effects on parent–infant attachment and stress regulation. 
Structured, attachment-sensitive, sleep hygiene–based educational interventions initiated 
during pregnancy remain limited. 
 
3. Study Objectives 
Primary Objectives: 
1. Evaluate the effectiveness of a structured Infant Sleep Hygiene Education Program on: 
o Parental self-efficacy regarding infant sleep 
o Infant sleep outcomes: night waking frequency, sleep duration, sleep onset 
latency, routine consistency 
Secondary Objectives: 
1. Examine adherence to program-recommended behaviors (bedtime routines, 
environmental hygiene, soothing strategies etc.) 
2. Assess infant sleep diary indicators, including bedtime/start of sleep routine 
3. Investigate parental self-efficacy as a potential mediator of the intervention’s effect on 
infant sleep outcomes 
4. Evaluate parental knowledge gain and satisfaction with the education program 
Study Hypotheses 
H1. Clinical and Psychosocial Effects 
• 
H1.1: The Comfort Theory–based Infant Sleep Hygiene Education Program delivered 
to pregnant women at 24–32 weeks gestation will have a significant effect on infants’ 
sleep habits. 
• 
H1.2: The program will significantly improve parental self-efficacy regarding infant 
sleep. 
• 
H1.3: Parental self-efficacy will play a significant mediating role in the program’s 
effect on infants’ sleep habits. 
H2. Evaluation of the Educational Program (Kirkpatrick Model) 
• 
H2.1 (Reaction – Level 1): Participants will report high levels of satisfaction with the 
Infant Sleep Hygiene Education Program. 
• 
H2.2 (Learning – Level 2): Participants’ knowledge of infant sleep hygiene will 
increase significantly after the program. 
• 
H2.3 (Behavior – Level 3): Parents will demonstrate higher levels of positive infant 
sleep-supportive practices in the postnatal period. 
• 
H2.4 (Results – Level 4): Outcomes on infant sleep habits and parental self-efficacy 
will be evaluated under the hypotheses outlined in H1. 

4. Study Design 
Randomized controlled trial with two arms: 
1. Intervention Arm: Infant Sleep Hygiene Education Program (structured prenatal 
sessions and postnatal follow-up support) 
2. Control Arm: Routine Antenatal Care (No Intervention) 
Randomization: Participants will be randomly allocated to the intervention or control group. 
Masking: Outcome assessors will be blinded to group allocation. Participant identifiers will 
be coded to maintain masking. 
5. Participants 
Population: Pregnant women, any self-identified gender, biologically female, ≥18 years old 
Healthy Volunteers: Yes 
Inclusion criteria 
1.    Being a primiparous pregnant woman (first pregnancy) 
2.    Being between 24 and 32 weeks of pregnancy 
3.    Having a risk-free pregnancy 
4.    Not having a mental disorder 
5.    Speaking and understanding Turkish as a native language 
6.    Being literate 
7.    Not having received training on infant sleep 
8.    Agreeing to participate in the study 
 
Exclusion criteria 
1.    The baby being born outside of the 38th to 42nd week of pregnancy 
2.    The baby having a birth weight of less than 2,500 grams or more than 4,000 grams 
3.    The baby being admitted to the neonatal intensive care unit after birth 
4.    The baby having a condition that affects sleep, such as colic or hernia 
5.    The baby having a chronic illness 
6.    The parent wanting to leave work 
6. Intervention Details 
 
Intervention Arm: 
• 
Developmentally appropriate sleep expectations 
• 
Infant temperament-sensitive approaches 
• 
Consistent and predictable bedtime routines and bedtime routine applications 
• 
Environmental sleep hygiene (light, noise, temperature) 
• 
Responsive soothing strategies 
• 
Parental coping and stress regulation skills 
Control Arm: 

• 
Routine antenatal care without structured sleep education 
7. Outcome Measures 
 
Primary Outcome Measures: 
Parental self-efficacy regarding infant sleep 
Baseline (prenatal), 1, 3, and 6 months postpartum 
Will be measured with the Turkish version of UPPSEISI 
Infant sleep habits and patterns 
Night waking, total sleep duration, sleep onset latency, sleep routine consistency 
1, 3, and 6 months postpartum 
 
Secondary Outcome Measures: 
Adherence to recommended sleep-supportive behaviors 
Infant sleep diary indicators, including bedtime/start of sleep routine 
Mediating role of parental self-efficacy 
Parental knowledge gain before and after education sessions 
Parental satisfaction after each session 
Attendance and engagement during sessions 
8. Statistical Analysis Plan 
• 
Software: SPSS 27.0 
• 
Descriptive Statistics: Frequency, percentage, mean, standard deviation 
• 
Normality Tests: Kolmogorov-Smirnov (n ≥ 30) 
• 
Parametric Tests: Applied if skewness and kurtosis indices within ±2 (George & 
Mallery, 2020) 
• 
Main Analysis: 
o Mixed ANOVA (Karma ANOVA) for repeated measures: group × time 
interactions on pre-test, post-test, and follow-up scores 
o If assumptions not met: Linear Mixed Models (LMM) 
• 
Mediation Analysis: Structural Equation Modeling (SEM) 
o Parental self-efficacy as mediator on infant sleep outcomes 
o Testing direct, indirect, moderator, and mediator effects 
o Fit indices: CFI, TLI, RMSEA, χ²/df 
9. Data Collection Procedures 
Pre-Implementation: 
After obtaining necessary ethics committee and institutional approvals, eligible pregnant 
women attending the Karabük Training and Research Hospital Obstetrics Outpatient Clinic 
“Pregnancy School” will be identified in consultation with the responsible education 
nurse/midwife. Women meeting inclusion criteria and registered at the Pregnancy School will 
be provided with detailed face-to-face information about the study and invited to participate in 

the pilot implementation. Written and verbal informed consent will be obtained from all 
participants who agree to join. 
Pilot Implementation: 
A pilot study will be conducted with 6 voluntary pregnant women (first pregnancy, 24–32 
weeks gestation, no pregnancy risks) to evaluate: 
• 
Comprehensibility of educational content 
• 
Session duration and suitability 
• 
Adequacy of materials 
• 
Reliability and clarity of measurement instruments 
• 
Identification of potential implementation issues 
• 
Researcher’s implementation skills 
If the pilot indicates insufficient power, the number of participants will be increased. 
Implementation Phases: 
1. Baseline (Pre-Test) Assessment and Intervention Delivery: 
Eligible pregnant women will be invited to participate, and written informed consent 
will be obtained. Participants will complete the Pregnancy Information Form and 
the Uppsala Parent Infant Sleep Self-Efficacy Scale (UPPSEISI) as pre-test 
measures. Participants will be assigned a participant ID number and randomized into 
the intervention or control group. Contact information will be collected to maintain 
communication via group-specific WhatsApp groups for follow-up and support. 
2. Intervention Delivery: 
A mutually convenient schedule for education sessions will be determined through 
WhatsApp polls. The intervention consists of six structured sessions, delivered twice 
per week in small groups (6 participants per group) at the hospital’s Pregnancy School 
unit. Prior to the first session, participants will be provided with an overview of the 
weekly program. Each session includes a module booklet for participants to reinforce 
and practice the learned content. Flexible scheduling allows participants who miss a 
session to attend another session within the same week. 
3. Post-Intervention (Post-Test) Assessment: 
After completion of the educational sessions, participants in both the intervention and 
control groups will complete the UPPSEISI again to assess changes in parental self-
efficacy. 
4. Follow-Up Assessments: 
• 
1 Month Postpartum: Participants will complete the Maternal and Infant 
Identification Form, the Revised Brief Infant Sleep Questionnaire (BISQ-R), and 
the Behavioral Tracking Form. Participants in the intervention group may request 
additional counseling. 

• 
3 Months Postpartum: Participants will complete the Maternal and Infant 
Identification Form, BISQ-R, Infant Sleep Diaries, and UPPSEISI. Counseling 
will continue for the intervention group if requested. 
• 
6 Months Postpartum: Participants will complete the Maternal and Infant 
Identification Form, BISQ-R, and UPPSEISI. After all follow-ups, control group 
participants will receive the full Comfort Theory–Based Infant Sleep Hygiene 
Education Program Module Booklet. All participants will receive identical 
educational materials. 
This structured data collection process ensures comprehensive evaluation of both the 
educational program’s impact on parental self-efficacy and infant sleep, as well as adherence 
to recommended sleep-supportive practices. 
10. Ethical Aspects of the Study 
The study will be conducted in accordance with the ethical principles outlined in the 
Declaration of Helsinki. Ethical approval for the study has been obtained from the Non-
Interventional Clinical Research Ethics Committee of Karabük University (2025/2459). 
Institutional approval will be obtained from Karabük Training and Research Hospital, where 
the study will be conducted. Before being included in the study, pregnant women will be 
verbally informed that participation is voluntary, that they can withdraw at any time, and that 
the study's purpose and data will be used solely for scientific purposes. Verbal and written 
consent (Informed Consent Form) will be obtained from individuals who agree to participate 
in the study. 
 
References 
Basınlı, K. B. E., & Kahraman, Ö. G. (2020). Uyku eğitim programının bebeklerin uyku 
alışkanlıkları üzerindeki etkisi. Erken Çocukluk Çalışmaları Dergisi, 4(3), 738–761. 
https://doi.org/10.24130/eccd-jecs.1967202043228  
Cato, K., Funkquist, E. L., & Karlsson Rosenblad, A. (2024). Instrument development and an 
intervention to increase parents' self-efficacy regarding their infant's sleep. Sexual & 
reproductive healthcare : official journal of the Swedish Association of Midwives, 39, 
100944. https://doi.org/10.1016/j.srhc.2023.100944  
Cook, G., Appleton, J. V., & Wiggs, L. (2022). UK parents' help-seeking for child sleep: A 
qualitative investigation into parental preferences and reservations about resources. Health & 
social care in the community, 30(6), e5378–e5390. https://doi.org/10.1111/hsc.13959 
de Groot, E. R., Wang, X., Wojtal, K., Janson, E., Alderliesten, T., Tataranno, M. L., Benders, 
M. J. N. L., & Dudink, J. (2024). Association between sleep stages and brain microstructure 

in preterm infants: Insights from DTI analysis. Sleep medicine, 121, 336–342. 
https://doi.org/10.1016/j.sleep.2024.07.021 
El-Sheikh, M., & Kelly, R. J. (2017). Family Functioning and Children's Sleep. Child 
development perspectives, 11(4), 264–269. https://doi.org/10.1111/cdep.12243 
Hernandez-Reif, M., & Gungordu, N. (2022). Infant sleep behaviors relate to their later 
cognitive and language abilities and morning cortisol stress hormone levels. Infant behavior & 
development, 67, 101700. https://doi.org/10.1016/j.infbeh.2022.101700 
Hiscock H, Davey MJ. Sleep disorders in infants and children. J Paediatr Child Health 
2018;54(9):941–4.  https://doi.org/10.1111/jpc.12033  
Hsu, P. W., Wu, W. W., Tung, Y. C., Thomas, K. A., & Tsai, S. Y. (2017). Parental 
professional help-seeking for infant sleep. Journal of clinical nursing, 26(23-24), 5143–5150. 
https://doi.org/10.1111/jocn.14061  
Hysing, M., Harvey, A. G., Linton, S. J., Askeland, K. G., & Sivertsen, B. (2016). Sleep and 
academic performance in later adolescence: results from a large population-based study. 
Journal of sleep research, 25(3), 318–324. https://doi.org/10.1111/jsr.12373 
McDowall, P. S., Galland, B. C., Campbell, A. J., & Elder, D. E. (2017). Parent knowledge of 
children's sleep: A systematic review. Sleep medicine reviews, 31, 39–47. 
https://doi.org/10.1016/j.smrv.2016.01.002  
Ophoff, D., Slaats, M. A., Boudewyns, A., Glazemakers, I., Van Hoorenbeeck, K., & 
Verhulst, S. L. (2018). Sleep disorders during childhood: A practical review. European 
Journal of Pediatrics, 177(5), 641–648. https://doi.org/10.1007/s00431-018-3116-z 
Oras, P., Ljungberg, T., Hellström-Westas, L., & Funkquist, E.-L. (2020). A breastfeeding 
support program changed breastfeeding patterns but did not affect the mothers’ self-efficacy 
in breastfeeding at two months. Early Human Development, 151, 105242. 
https://doi.org/10.1016/j.earlhumdev.2020.105242  
Svavarsdottir EK, Flygerning KB, Sigurdardottir AO. (2025). Contribution of the Brief 
Family Strength–Oriented Therapeutic Conversation Intervention to Early Childhood Sleep 
Health: A Quasi-Experimental Study. Journal of Family Nursing, 31(1), 45-57. 
https://doi.org/10.1177/10748407241313463  
Sviggum, G., Sollesnes, R., & Langeland, E. (2018). Parents' experiences with sleep problems 
in children aged 1-3 years: a qualitative study from a health promotion perspective. 
International journal of qualitative studies on health and well-being, 13(1), 1527605. 
https://doi.org/10.1080/17482631.2018.1527605  

Tham, E. K., Schneider, N., & Broekman, B. F. (2017). Infant sleep and its relation with 
cognition and growth: a narrative review. Nature and science of sleep, 9, 135–149. 
https://doi.org/10.2147/NSS.S125992 
Tikotzky, L., Volkovich, E., & Meiri, G. (2021). Maternal emotional distress and infant sleep: 
A longitudinal study from pregnancy through 18 months. Developmental psychology, 57(7), 
1111–1123. https://doi.org/10.1037/dev0001081  
Vertsberger, D., Tikotzky, L., Baruchi, O., & Knafo-Noam, A. (2021). Parents' Perceptions of 
Infants' Nighttime Sleep Patterns Predict Mothers' Negativity: A Longitudinal Study. Journal 
of developmental and behavioral pediatrics : JDBP, 42(4), 307–313. 
https://doi.org/10.1097/DBP.0000000000000899  
Vieira, A. R., dos Santos, J., Paulo S. (2020). Parental education and better sleep in infants: a 
systematic review. Pediatria, 16(2), 190-197. https://doi.org/10.15557/PiMR.2020.0036  
Werner A, Mayer A, Lohaus A. (2022). Sleep-related parenting self-efficacy and parent-
reported sleep in young children: A dyadic analysis of parental actor and partner effects. Sleep 
Health, 8(1), 54–61. https://doi.org/10.1016/j.sleh.2021.11.004  
Williamson, A. A., Mindell, J. A., Hiscock, H., & Quach, J. (2019). Child sleep behaviors and 
sleep problems from infancy to school-age. Sleep medicine, 63, 5–8. 
https://doi.org/10.1016/j.sleep.2019.05.003