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Effects of Progressive Muscle Relaxation Exercises During Pregnancy.

Effects of Progressive Muscle Relaxation Exercises on Lumbopelvic Pain and Insomnia During Pregnancy.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06536764
Enrollment
76
Registered
2024-08-05
Start date
2024-08-01
Completion date
2025-08-31
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Lumbopelvic Pain

Keywords

Lumbopelvic pain, Insomnia, Pregnancy, Progressive Muscle Relaxation Exercises

Brief summary

Lumbopelvic pain (LPP) during pregnancy is defined as pregnancy-related low back, or pelvic girdle pain. Pregnancy is a significant time for sleep disruptions as well.PMR involves systematically tensing and relaxing different muscle groups in the body, starting from the feet or hands and progressing through the body. This study aims to evaluate the impact of progressive muscle relaxation (PMR) exercises on the alleviation of low back pain and sleeplessness in pregnant women in their pregnancy.

Detailed description

Literature suggests that Pregnancy involves hormonal and biomechanics adjustments, leading to changes in body systems for a secure fetus development. Painful symptoms and sleep disorders are common complaints, often present in the same individual.The exact cause of low back pain during pregnancy is not fully understood, but it is often linked to biomechanical, vascular, and hormonal changes.In the third trimester, 98% of women experience sleep difficulties, primarily caused by backache, urinary frequency, fetal movements, GERD, and leg discomfort. The PMR technique involves deep breathing and progressive relaxation (tense-release) of major muscle groups. The technique promotes systematic relaxation of the major muscle groups of the body with the goal of physical and mental relaxation, reducing the response to stress, reducing skeletal muscle contractions, and decreasing pain sensations.

Interventions

Progressive muscle Relaxation exercises will be performed by this group.Advise women to sit in chair. The therapist's voice will then instruct them to contract and release different muscle groups. They will practice tensing a muscle group until they feel the slight contraction and then release it, simultaneously contracting and relaxing all other muscle groups.Practice will progress in the same manner, starting with the muscles in the feet, then the calf, thigh, gluteal muscles, abdomen, chest, hands, forearms, arms, shoulders, neck, face, and finally the forehead muscles .

OTHERConventional Therapy(Hot pack,TENS,Patient Education)

Conventional therapy including hot pack and TENS will be applied for 10 minutes each. Meanwhile, patients will be given education to ease back pain and improve sleep.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

There will be comparison between two groups, experimental and control group.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant females with Age 20-40 years.During second and third trimester with * Uncomplicated pregnancies.Pregnancy related LBP \>3 on NPRS & Insomnia severity index (ISI) \>10 score.Posterior lumbopelvic pain

Exclusion criteria

* Patients with Anterior Lumbopelvic Pain. * Hemodynamically significant heart disease, * Restrictive lung disease, * Incompetent cervix/cerclage, * Multiple gestation at risk for premature labor & Persistent bleeding.

Design outcomes

Primary

MeasureTime frameDescription
Numeric Pain Rating ScaleChanges from Baseline to 6 weeksThe 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable).
Pittsburgh Sleep Quality Index (PSQI)Changes from Baseline to 6 weeks.The PSQI has 19 self-rated questions and five questions rated by a roommate or bed partner. The self-rated questions are combined into seven component scores, each with a range of 0-3, with 3 indicating the greatest dysfunction. The component scores are then added together to produce a global score, with a range of 0-21 points, with 0 indicating no difficulty and 21 indicating severe difficulties in all areas. Higher scores indicate worse sleep quality.
Insomnia severity indexChanges from Baseline to 6 weeksThe questionnaire uses Likert -type scales to rate each element, with scores ranging from 0 to 4, with higher scores indicating more severe insomnia symptoms.Total score of 0-7 indicating no significant insomnia, 8-14 indicating sub threshold insomnia, 15-21 indicating clinical insomnia (moderate severity), and 22-28 indicating clinical insomnia (severe).

Secondary

MeasureTime frameDescription
Oswestry Low Back Pain Disability QuestionnaireChanges from Baseline to 6 weeksThis tool is used to assess the functional status of patients with low back pain, assessing ten daily functions and scoring them on a 0-5 scale, with the highest scoring statement indicating the true disability.0 - 4 indicationg No disability,5 - 14 Mild disability,15 - 24 Moderate disability ,25 - 34 Severe disability and 35 - 50 means Completely disabled.
Short Form-36Changes from Baseline to 6 weeksThe questionnaire consists of 36 items assigned to 8 subscales.These 8 scales are further clustered into the physical component summary (physical function, role physical, bodily pain, and general health) and the mental component summary (vitality, social function, role-emotional, and mental health).High scores on all subscales indicate deterioration in QOL.

Countries

Pakistan

Contacts

Primary ContactHuma Riaz, PhD
huma.riaz@riphah.edu.pk03215242874

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026