Clinical trial NCT05851001: Effects of Progressive Muscle Relaxation Exercises During Pregnancy
Official title: Effects of Progressive Muscle Relaxation Exercises and Relaxation Music on the Severity of Restless Legs Syndrome and Sleep Quality During Pregnancy: A Randomized Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Keywords: Progressive relaxation exercises
Sleep quality
Relaxation music
Pregnancy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 67
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized-controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participants were allocated into three groups; the control group, progressive muscle relaxation (PMR) group and relaxation music (RM) group. The PMR and RM programs were explained toall participants, and the first program was tested under the supervision of the researcher. PMR and RM group participants performed the program daily throughout 4 weeks. Severity of RLS with the International Restless Leg Syndrome Scale (IRLSS) and sleep quality with the Pittsburgh Sleep Quality Index (PSQI) were assessed at baseline, 2 and 4 weeks for all the groups.

Detailed description: A CD recorded by the Turkish Psychological Association was provided to explain relaxation techniques to PMR group participants. The CD contains relaxation exercises instructions and there is relaxing music in the background. This CD consists of two parts. The first part(11 minutes) gives short information about the content and how exercises should be done. It consists of information about deep relaxation. In the second part, there are 27 minutes of relaxation exercises accompanied by command with background music.

PMR exercise consists of four stages: stretching-relaxation (1st stage -approximately 20 minutes), autogenic training - only relaxation (2nd stage approximately 10 minutes), deep breathing training-breathing relaxation (3rd stage approximately 3-4 minutes), rapid relaxation (4th stage--a few seconds). In the first stage, the participant was instructed to first stretch and then relax the specified muscle group (hand, forearm, upper arm, forehead, cheek, nose, chin, neck, chest, shoulder, waist, abdomen, stomach, hip, calf, foot) in sequence. The participant was asked to constantly compare the feeling of tension that shehas just experienced with the feeling of relaxation later.

Another CD recorded by the Turkish Psychological Association was provided to RM group participants. It consists of 30 minutes relaxing music only.The participant was asked to just listen to music with without working in a private room.

Eligibility criteria: Inclusion Criteria:

1. diagnosed with RLS by a physician
2. 27 to 34 weeks gestation
3. aged 20 to 35 years
4. able to understand and answer questions in the scale and forms
5. having a CD player

Exclusion Criteria:

* have

  1. vision-hearing problems
  2. chronic disease (hypertension, diabetes mellitus, heart disease, etc.)
  3. any psychiatric diagnosis
  4. multiple pregnancy
  5. rheumatic disease (to avoid difficulties in assessing the severity of RLS)
  6. lumbar hernia and low back pain complaints (to avoid difficulties in assessing the severity of RLS)
  7. varicose veins in the legs (to avoid difficulties in assessing the severity of RLS)

Primary outcomes:
measure: Severity of Restless leg syndrome
timeFrame: 10 minutes.
Secondary outcomes:
measure: Sleep quality
timeFrame: 24 minutes.
Other outcomes:
Locations:
Study officials:
References: