Effects of Progressive Muscle Relaxation Exercises During Pregnancy.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Lumbopelvic Pain
• Intervention / Treatment: Other: Progressive Muscle Relaxation Exercises; Other: Conventional Therapy(Hot pack,TENS,Patient Education)

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huma Riaz, PhD; Phone Number: 03215242874; Email: huma.riaz@riphah.edu.pk

Study Locations

• Pakistan
  • Azad Jammu & Kashmir
    • Mirpur, Azad Jammu & Kashmir, Pakistan, 10250
      • Recruiting
      • Samra Yosaf Materniy Clinic
      • Contact: Ayesha Razzaq, MSPT(WHPT); Phone Number: 03485261455; Email: ayesharazzaqar507@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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 .
Active Comparator: Control Group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Low Back Pain Disability Questionnaire	This 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.	Changes from Baseline to 6 weeks
Short Form-36	The 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.	Changes from Baseline to 6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Huma Riaz, PhD, Ripha International University, Islambad, Pakistan; Principal Investigator: Ayesha Razzaq, MSPT, Ripha International University, Islambad, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Insomnia; Progressive Muscle Relaxation Exercises; Lumbopelvic pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: Ayesha Razzaq

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No