The Development and Evaluation of Sleep Intervention for Perinatal Family
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaipei Medical University
About this trial
Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. Effective sleep interventions are vital for family health.
Objectives: To develop a sleep intervention for mother-father-infant triads, and to evaluate the effects on sleep improvement, emotional distress, and infant health outcomes.
Methods: In this proposal, we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners. Mother-father-infant triads will be recruited and randomly allocated to the intervention group (receiving a sleep intervention) or the control group. Data will be collected with repeated measures, and the relationship between studied variables will be analyzed with descriptive and inferential statistics.
Anticipatory results: The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
First-time mothers and their partners aged 20 and older;
Currently 30 weeks gestation or more, singleton;
insomnia severity index score greater than 10;
living with a husband or partner;
Disqualifiers
sleep disorders, depression or anxiety disorders;
medical diseases with abnormal heart rate variability, or arrhythmia;
taking medicines that may affect the autonomic nervous system or
night shift workers;
Trial design
Design model
Parallel
Treatments tested in this trial
sleep intervention
BehavioralAt the beginning of the intervention, participants will have an orientation and overview of the program. Then, participants will follow the curriculum of modules, and professional feedback to complete the intervention.
Control group
BehavioralParticipants in control group will follow standardized usual care and a perinatal health booklet
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: sleep interventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia Severity Index
The Chinese version of the Insomnia Severity Index (ISI) is used to measure the severity of insomnia symptoms, a higher score indicates more severe insomnia symptoms.
Time frame
baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartumSecondary outcomes
1
Sleep quality
The 19-item Chinese version of the Pittsburgh Sleep Quality Index (PSQI), will be used to measure sleep quality and sleep disturbance, higher score indicates worse sleep quality
Time frame
baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months2
Sleep duration using actigraphy
The Actiwatch will be used to collect objective data of sleep duration
Time frame
baseline, postpartum 1 month, 3 months, and 6 months.3
Sleep sleep onset latency using actigraphy
The Actiwatch will be used to collect objective data of sleep onset latency
Time frame
baseline, postpartum 1 month, 3 months, and 6 months.4
Sleep efficacy using actigraphy
The Actiwatch will be used to collect objective data of sleep efficacy
Time frame
baseline, postpartum 1 month, 3 months, and 6 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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