Effects of Progressive Muscle Relaxation Exercises During Pregnancy.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorRiphah International University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Patients with Anterior Lumbopelvic Pain.
Hemodynamically significant heart disease,
Restrictive lung disease,
Incompetent cervix/cerclage,
Trial design
Design model
Parallel
Treatments tested in this trial
Progressive Muscle Relaxation Exercises
Other interventionProgressive 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 interventionConventional 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Interventional groupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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").
Time frame
Changes from Baseline to 6 weeks2
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.
Time frame
Changes from Baseline to 6 weeks.3
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).
Time frame
Changes from Baseline to 6 weeksSecondary outcomes
1
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.
Time frame
Changes from Baseline to 6 weeks2
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.
Time frame
Changes from Baseline to 6 weeksSponsors and contacts
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Source ClinicalTrials.gov