Effects of Progressive Muscle Relaxation Exercises During Pregnancy.

NCT06536764 | Recruiting

• 1 other identifier: Ayesha Razzaq
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbopelvic Pain; Insomnia

Keywords

Lumbopelvic pain; Insomnia; Pregnancy; Progressive Muscle Relaxation Exercises

Outcome Measures

Primary Outcomes (3)

• Numeric Pain Rating Scale

  The 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").

  Changes from Baseline to 6 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  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.

  Changes from Baseline to 6 weeks.

• Insomnia severity index

  The 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).

  Changes from Baseline to 6 weeks

Secondary Outcomes (2)

• Oswestry Low Back Pain Disability Questionnaire

  Changes from Baseline to 6 weeks

• Short Form-36

  Changes from Baseline to 6 weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

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.

Other: Progressive Muscle Relaxation Exercises

Control Group

ACTIVE COMPARATOR

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

Other: Conventional Therapy(Hot pack,TENS,Patient Education)

Interventions

Progressive Muscle Relaxation Exercises 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 .

Interventional group

Conventional Therapy(Hot pack,TENS,Patient Education) 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.

Control Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Samra Yosaf Materniy Clinic

Mirpur, Azad Jammu & Kashmir, 10250, Pakistan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Huma Riaz, PhD

  Ripha International University, Islambad, Pakistan

  STUDY CHAIR

• Ayesha Razzaq, MSPT

  Ripha International University, Islambad, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huma Riaz, PhD

CONTACT

03215242874; huma.riaz@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: August 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)