Effects of Progressive Muscle Relaxation Exercises During Pregnancy.
- Conditions
- Lumbopelvic PainInsomnia
- Interventions
- Other: Progressive Muscle Relaxation ExercisesOther: Conventional Therapy(Hot pack,TENS,Patient Education)
- Registration Number
- NCT06536764
- Lead Sponsor
- Riphah International University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 76
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional group Progressive Muscle Relaxation Exercises 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. Control Group Conventional Therapy(Hot pack,TENS,Patient Education) This group will receive Conventional therapy 2 sessions per week for 6 weeks. Conventional therapy involves hot pack, TENS and patient education.
- Primary Outcome Measures
Name Time Method 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.
Numeric Pain Rating Scale Changes from Baseline to 6 weeks 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").
Insomnia severity index Changes from Baseline to 6 weeks 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).
- Secondary Outcome Measures
Name Time Method Oswestry Low Back Pain Disability Questionnaire Changes from Baseline to 6 weeks 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.
Short Form-36 Changes from Baseline to 6 weeks 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.
Trial Locations
- Locations (1)
Samra Yosaf Materniy Clinic
🇵🇰Mirpur, Azad Jammu & Kashmir, Pakistan