NCT06890910

Evidence Based Intervention for Improving Sleep Quality Among Obese Pregnant Women

Effect of Evidence Based Intervention on Sleep Quality Among Obese Pregnant Women:A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Sleep is essential for maternal and fetal health, with adequate sleep being crucial for energy, fetal development, and overall pregnancy well-being. However, sleep disturbances such as insomnia, sleep-disordered breathing (SDB), and restless legs syndrome (RLS) affect up to 83.5% of pregnant women, especially in the third trimester. These disturbances are linked to hormonal, anatomical, physiological, and psychological changes during pregnancy, as well as conditions like obesity, gestational hypertension, and gestational diabetes mellitus (GDM). Poor sleep quality can lead to cognitive impairment, fatigue, and increased risks for pregnancy complications, yet sleep disorders are often overlooked in prenatal care. Obesity further exacerbates sleep disturbances, as excessive weight gain impacts endocrine pathways, increasing the risk of obstructive sleep apnea (OSA) and poor sleep quality. Research highlights the importance of good sleep hygiene, which includes a controlled sleep environment, dietary adjustments, and relaxation techniques such as progressive muscle relaxation (PMR). Behavioral therapies like relaxation exercises have shown promise in improving sleep, but there is limited high-quality research on their effectiveness during pregnancy. Significance of the Study Given the high prevalence of sleep disturbances in pregnancy and their potential negative effects on maternal and neonatal outcomes, this study aims to evaluate the impact of evidence-based interventions on sleep quality in obese pregnant women. Sleep disorders during pregnancy are associated with an increased risk of GDM, hypertension, cardiometabolic disorders, and postpartum depression. Effective interventions, such as sleep hygiene education and relaxation techniques, are cost-effective, feasible, and can be integrated into routine prenatal care. This study will contribute to evidence-based guidelines that could improve sleep health in pregnancy, benefiting both maternal and fetal well-being. Aim \& Hypothesis The study aims to assess the effectiveness of evidence-based interventions in improving sleep quality among obese pregnant women through a randomized controlled trial (RCT). It hypothesizes that obese pregnant women receiving the intervention will demonstrate better sleep quality than those receiving routine antenatal care. Methods A parallel-group, open-label RCT was conducted in the antenatal clinic of Cairo University Hospitals. A total of 100 pregnant women meeting the eligibility criteria (BMI ≥30, gestational age 28-34 weeks, presence of sleep disturbance) were randomly assigned to either the intervention group (n=50) or control group (n=50). Exclusion criteria included high-risk pregnancies, known fetal abnormalities, preexisting psychiatric conditions, or prior treatment for sleep disorders. Data Collection Tools: Structured Interview Schedule - Collected demographic and obstetric history. Global Sleep Assessment Questionnaire (GSAQ) - Screened for sleep disturbances. Pittsburgh Sleep Quality Index (PSQI) - Assessed overall sleep quality. Sleep Hygiene Index (SHI) - Evaluated sleep habits. Intervention Study Group: Received sleep hygiene education and relaxation training, including: Personal habits (consistent sleep schedule, dietary adjustments, avoiding caffeine, using warm milk). Sleep environment modifications (comfortable bed, removing electronic devices, noise control). Stimulus control (associating the bed with sleep only, engaging in relaxation activities if unable to sleep). Progressive Muscle Relaxation (PMR): Participants were trained in a structured relaxation technique, guided through video demonstrations, and given a handbook. They were instructed to practice PMR twice daily for four weeks. Control Group: Received routine antenatal care, including general pregnancy monitoring without additional sleep-focused interventions. Follow-up \& Monitoring Participants in the intervention group were followed up weekly via phone calls to ensure adherence to the interventions. Both groups underwent reassessments after four weeks using the same sleep evaluation tools. Outcome Measures Primary Outcome: Improved sleep quality (measured by PSQI) and Improved sleep hygiene (measured by SH . Secondary Outcome:

Conditions

• Sleep Disorders
• Obese Pregnant Women

Interventions

Type	Name	Description
OTHER	evidence based intervention	sleep hygiene education. This education focused on four main aspects as follows: * Personal habits: Women were educated on establishing a regular bedtime routine, engaging in regular exercise, maintaining a healthy diet, avoiding caffeine and nicotine before bedtime, consuming adequate calcium and magnesium, drinking warm milk before sleep, and avoiding gas-producing foods or excessive fluid intake before bed. * Sleep environment: Women were advised to associate the bedroom only with sleep and intimacy, remove electronic devices, maintain a dark, quiet, and cool environment, ensure mattress and pillows were comfortable, and eliminate noise disturbances such as television. * Stimulus control: Participants were instructed to use the bed only for sleeping, avoid staying in bed if unable to sleep, and engage in minimally stimulating activities instead of worrying about insomnia. * Progressive muscle relaxation: Women in the study group received an educational session on the Jacobson's met

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-12-15
• Completion: 2025-01-15
• First posted: 2025-03-24
• Last updated: 2025-03-24

Locations

1 site across 1 country: Egypt