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NCT Number: NCT06536764

Effects of Progressive Muscle Relaxation Exercises 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.

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Key information

Conditions

Lumbopelvic Pain Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samra Yosaf Materniy Clinic

Mirpur, Azad Jammu & Kashmir, 10250, Pakistan

Location status: Recruiting

Location contact

Ayesha Razzaq, MSPT(WHPT)

CONTACT

[email protected]

03485261455

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

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.

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 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").

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  3. Insomnia severity index

    Time frame: 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 outcomes

  1. Oswestry Low Back Pain Disability Questionnaire

    Time frame: 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.

  2. Short Form-36

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huma Riaz, PhD

CONTACT

[email protected]

03215242874

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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