A Nurse-Led Sleep Hygiene and Progressive Muscle Relaxation Intervention on Sleep Quality Among Obese Pregnant Women

August 26, 2026 updated by: Mohamed Yehia Ali Mohamed, Cairo University

Effect of a Nurse-Led Sleep Hygiene and Progressive Muscle Relaxation Intervention on Sleep Quality Among Obese Pregnant Women: A Randomized Controlled Trial

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:

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Kase AlAini/El-Manial
      • Cairo, Kase AlAini/El-Manial, Egypt, 11562
        • Faculty of nursing at Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • primigravida or multigravida women with any type of sleep disorder during pregnancy either insomnia, obstructive sleep apnea, restless leg syndrome, parasomnias; age 18-40 years old; obese women with body mass index (BMI) ≥ 30; being in the third trimester of pregnancy(28-34weeks of gestation)

Exclusion Criteria:

  • having known risk of current pregnancy (preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios, twin pregnancy, etc.); having known problem about fetus health (IUGR, anomaly, etc.); diagnosed with a sleep disorder for a different reasons and received treatment for it; history of psychiatric or somatic disorders; recent administration of psychoactive, sedative, or narcotic medications, and use of caffeine ( more than 8cups of coffee or 16 cups of tea/day).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
Experimental: study group
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: four weeks after intervention
this outcome was assessed using Pittsburgh Sleep Quality Index (PSQI) . The PSQI is acommon method of examining the quality of sleep during pregnancy. The questionnaire includes seven components. These components include subjective sleep quality, sleep duration, sleep latency, sleep disturbances, the use of sleeping medication, daytime dysfunction habits and sleep efficiency.Each item is rated on a 0-3 scale, (zero) indicate very good, (1) indicate good,(2) indicate bad, and (3) indicate very bad.The sum of seven component scores gives the global PSQI score between 0 and 21. Ascore (0-4) indicated good sleep quality,score (5-10) indicated moderate sleep quality and score (11-21) indicated good sleep quality. The Cronbach's alpha of this questionnaire was calculated to be (0.83)
four weeks after intervention
sleep hygiene
Time Frame: four weeks after intervention
sleep hygiene was assessed using Sleep Hygiene Index (SHI). The tool was used as a self- report questionnaire, which can measure sleep hygiene. Sleep hygiene index has 13 items asking about sleeping habits as long naps , inconsistent bedtime ,inconsistent wake time ,late-night exercise , excessive time in bed ,substance use before bed ,stimulating activities before bed ,going to bed stressed ,using bed for non-sleep activities, uncomfortable bed, uncomfortable bedroom environment ,doing work before bed ,overthinking in bed. rating on a scale from 0 (never) to 4 (always). The global assessment score of SHI ranges from 0-52. Higher scores of SHI (score ≥ 16) indicate poor sleep hygiene and lower than 16 indicate good sleep hygiene. The reliability of the questionnaire was estimated to be(0.83)
four weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mohamed yehia Ali

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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