Effects of Progressive Muscle Relaxation Exercises During Pregnancy.

NCT ID: NCT06536764

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-08-31

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.

Conditions

Lumbopelvic Pain; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interventional group

This group will receive Conventional therapy (hot pack, TENS, patient education) \& Progressive muscle Relaxation exercises on low back 2 sessions per week for 6 weeks.

Group Type: EXPERIMENTAL

Progressive Muscle Relaxation Exercises

Intervention Type: OTHER

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 .

Control Group

This group will receive Conventional therapy 2 sessions per week for 6 weeks. Conventional therapy involves hot pack, TENS and patient education.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy(Hot pack,TENS,Patient Education)

Intervention Type: OTHER

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.

Interventions

Progressive Muscle Relaxation Exercises

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 .

Intervention Type: OTHER

Conventional 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huma Riaz, PhD

Role: STUDY_CHAIR

Ripha International University, Islambad, Pakistan

Ayesha Razzaq, MSPT

Role: PRINCIPAL_INVESTIGATOR

Ripha International University, Islambad, Pakistan

Locations

Samra Yosaf Materniy Clinic

Mirpur, Azad Jammu & Kashmir, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Huma Riaz, PhD

Role: CONTACT

huma.riaz@riphah.edu.pk

03215242874

Facility Contacts

Ayesha Razzaq, MSPT(WHPT)

Role: primary

ayesharazzaqar507@gmail.com

03485261455

Other Identifiers

Ayesha Razzaq

Identifier Type: -

Identifier Source: org_study_id