Clinical trial NCT06536764: Effects of Progressive Muscle Relaxation Exercises During Pregnancy.
Official title: Effects of Progressive Muscle Relaxation Exercises on Lumbopelvic Pain and Insomnia During Pregnancy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbopelvic Pain
Insomnia
Keywords: Lumbopelvic pain
Insomnia
Pregnancy
Progressive Muscle Relaxation Exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 76
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be comparison between two groups, experimental and control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Changes from Baseline to 6 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Changes from Baseline to 6 weeks.
measure: Insomnia severity index
timeFrame: Changes from Baseline to 6 weeks
Secondary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: Changes from Baseline to 6 weeks
measure: Short Form-36
timeFrame: Changes from Baseline to 6 weeks
Other outcomes:
Locations:
city: Mirpur
country: Pakistan
facility: Samra Yosaf Materniy Clinic
state: Azad Jammu & Kashmir
Study officials:
affiliation: Ripha International University, Islambad, Pakistan
name: Huma Riaz, PhD
role: STUDY_CHAIR
affiliation: Ripha International University, Islambad, Pakistan
name: Ayesha Razzaq, MSPT
role: PRINCIPAL_INVESTIGATOR
References: