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Health Care Seeking BehaviorNCT05508542

Progressive Relaxation Exercises and Sleep, Anxiety and Stress in Risky Pregnants

A study testing Progressive relaxation exercises in people with Health Care Seeking Behavior, run by Cukurova University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was planned as a randomized controlled quasi-experimental study to determine the effect of progressive relaxation exercises on sleep quality, anxiety and stress levels in risky pregnant women. Read more about this study

Who is it for?
Ages 15 to 49 years, women only
Conditions the study is for
Health Care Seeking Behavior
What is being tested?
Progressive relaxation exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Aug 2022to 30 Dec 2023
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • At least primary school graduate,
  • No communication problem,
  • Not having any psychiatric disease,
  • Diagnosed with a risky pregnancy for at least one month,
  • In the last trimester of pregnancy,
  • Having a smart phone,
  • Internet access

Who cannot join

  • Pregnant women diagnosed with restless legs syndrome during treatment and follow-up,
  • Women who gave birth before the end of the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Cukurova Unıversity

    Adana, 01260

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Progressive Relaxation Exercises on Sleep Quality, Anxiety and Stress Levels in Risky Pregnants

This study was planned as a randomized controlled quasi-experimental study to determine the effect of progressive relaxation exercises on sleep quality, anxiety and stress levels in risky pregnant women. "Personal Information Form", "Pittsburgh Sleep Quality Index (PUKI)" to measure the sleep quality of pregnant women, "Perinatal Anxiety Screening Scale" to determine the anxiety levels of pregnants, "Pregnancy Stress Scale" to determine the perceived stress level of pregnants, which were created by the researchers in the direction of the literature in data collection. Evaluation Scale".The universe of the research, T.C. It will consist of pregnant women who are hospitalized with the diagnosis of risky pregnancy in the Ministry of Health Adana City Training and Research Hospital Gynecology and Obstetrics Clinics. The sample size was determined as 15 patients to compare the means between the two groups. With an expected dropout rate of 10% and to ensure the adequacy of the final sample size, 17 patients were selected per group.Relaxation exercises are easy to apply, economical, safe and effective non-pharmacological applications that can be used independently by nurses and midwives. By ensuring the management of risky pregnancies, it will support the protection and development of public health by ensuring the protection of both women and fetus health.

Read the detailed description

This study was planned as a randomized controlled quasi-experimental study to determine the effect of progressive relaxation exercises on sleep quality, anxiety and stress levels in risky pregnant women.

H1-1: There is a significant difference between the sleep quality posttest total score averages.

H1-2: There is a significant difference between the anxiety level posttest total score averages.

H1-3: There is a significant difference between the stress level posttest total score averages.

The universe of the research, T.C. It will consist of pregnant women who are hospitalized with the diagnosis of risky pregnancy in the Ministry of Health Adana City Training and Research Hospital Gynecology and Obstetrics Clinics. "Personal Information Form", "Pittsburgh Sleep Quality Index (PUKI)" to measure the sleep quality of pregnant women, "Perinatal Anxiety Screening Scale" to determine the anxiety levels of pregnants, "Pregnancy Stress Scale" to determine the perceived stress level of pregnants, which were created by the researchers in the direction of the literature in data collection. Evaluation Scale".Intervention Group The pregnant women who were diagnosed with a risky pregnancy, admitted to the clinic and met the research participation criteria will be informed about the study by the researchers, and verbal and written consents of the pregnant women who accepted to participate in the study will be obtained and the study will begin.

Personal information form, Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be applied to the pregnant women at the first interview. Afterwards, the researcher will first give training on progressive relaxation exercises to the patient in the patient's room. Afterwards, the Relaxation Exercises CD will be played and the exercises will be performed with the patient along with the CD. A relaxation exercise program will be installed on the patients' phones via the Whatsapp application. It is planned that the trainings will be applied to the patients one-to-one and will last an average of 40-45 minutes for each patient.

After these trainings are completed, a booklet will be given to the patients that will contribute to the correct practice of relaxation exercises on their own. Patients will be asked to practice relaxation exercises by listening to the programs downloaded to their phones at least three times a week for 4 weeks. Researchers will follow the patients over the phone for 4 weeks.

In the final test phase; Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be re-administered 4 weeks after the start of exercise practices.

Control Group In the control group, pregnant women who meet the research participation criteria will be informed about the study by the researchers, verbal and written consents of the pregnant women who accepted to participate in the study will be obtained and data collection will begin.

The control group will receive routine nursing care in the clinic and no intervention will be made to this group. Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be applied at the first interview.

In the post-test phase, 4 weeks after the start of the first interview, the Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be administered again.

In order to prevent the pregnant women in the control group from being affected by the pregnant women in the intervention group, pregnant women in different rooms will be selected for the intervention and control group.Progressive relaxation exercises are a non-pharmacological method that can be easily applied by both nurses and pregnant women in the management of life-threatening risky pregnancies for maternal and fetal health. Improving the sleep quality of pregnant women, reducing perceived stress and anxiety levels will increase their quality of life. By ensuring the management of risky pregnancies, it will support the protection and development of public health by ensuring the protection of both women and fetus health. The work done in this area is limited. At the end of the study, it is thought that it will contribute to the literature.

Being tested
Progressive relaxation exercises
Keywords
risky pregnancy, progressive relaxation exercises, anxiety, stress, nursing
Medical subject headings
Patient Acceptance of Health Care, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive relaxation exercisesBehavioural

    Personal information form, Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be applied to the pregnant women at the first interview. Afterwards, the researcher will first give training on progressive relaxation exercises to the patient in the patient's room. Afterwards, the Relaxation Exercises CD will be played and the exercises will be performed with the patient along with the CD. A relaxation exercise program will be installed on the patients' phones via the Whatsapp application. It is planned that the trainings will be applied to the patients one-to-one and will last an average of 40-45 minutes for each patient.

Study groups in NCT05508542
Study groupRoleWhat they receive
Intervention group: Progressive relaxation exercisesExperimentalAfterwards, the researcher will first give training on progressive relaxation exercises to the patient in the patient's room. A relaxation exercise program will be installed on the patients' phones via the Whatsapp application. It is planned that the trainings will be applied to the patients one-to-one and will last an average of 40-45 minutes for each patient. After these trainings are completed, a booklet will be given to the patients that will contribute to the correct practice of relaxation exercises on their own. Patients will be asked to practice relaxation exercises by listening to the programs downloaded to their phones at least three times a week for 4 weeks. In the final test phase; Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be re-administered 4 weeks after the start of exercise practices.
Receives: Behavioral: Progressive relaxation exercises
No Intervention: Standard care groupNo interventionStandard care group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburgh Sleep Quality Index (PUKI)

    It was developed by Buysse et al. in 1989 (Buysse et al., 1989). The Turkish validity and reliability study of the scale was conducted by Ağargün et al. (1996) and the Cronbach Alpha internal consistency coefficient was found to be 0.80.A total score higher than 5 indicates poor sleep quality .

    Measured: change in sleep quality at four weeks

Secondary outcomes (1)
  1. Prenatal Anxiety Screening Scale

    It was developed by Somerville et al. in 2013 and validated and reliable in 2019 by Yazıcı et al. The scale consists of 31 items. The four sub-dimensions of the scale are: (1) acute anxiety and adjustment disorder, (2) general anxiety and specific fears, (3) perfectionism, control and trauma, and (4) social anxiety. Cronbach Alpha was found to be 0.95. The cut-off point on the original scale was calculated as 26, minimum anxiety symptoms 0-20, mild-moderate 21-41, and severe anxiety 42-93

    Measured: change in anxiety level at four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start18 Aug 2022
  3. Primary completion21 Nov 2023
  4. Study completion30 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05508542
Sponsor's protocol ID
34
Status last verified
Jan 2026
First submitted
18 Aug 2022
Last updated
16 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Somerville S, Dedman K, Hagan R, Oxnam E, Wettinger M, Byrne S, Coo S, Doherty D, Page AC. The Perinatal Anxiety Screening Scale: development and preliminary validation. Arch Womens Ment Health. 2014 Oct;17(5):443-54. doi: 10.1007/s00737-014-0425-8. Epub 2014 Apr 4.

    PubMed 24699796
  • Akmese ZB, Oran NT. Effects of Progressive Muscle Relaxation Exercises Accompanied by Music on Low Back Pain and Quality of Life During Pregnancy. J Midwifery Womens Health. 2014 Sep-Oct;59(5):503-9. doi: 10.1111/jmwh.12176. Epub 2014 Jun 25.

    PubMed 24965313

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