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

NCT05508542 | Completed

• 1 other identifier: 34
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. "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.

Conditions

Health Care Seeking Behavior

Keywords

risky pregnancy; progressive relaxation exercises; anxiety; stress; nursing

Outcome Measures

Primary Outcomes (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 .

  change in sleep quality at four weeks

Secondary Outcomes (1)

• Prenatal Anxiety Screening Scale

  change in anxiety level at four weeks

Other Outcomes (1)

• Pregnancy Stress Rating Scale (GSDS-36)

  change in stress level at four weeks

Study Arms (2)

Intervention group: Progressive relaxation exercises

EXPERIMENTAL

Afterwards, 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.

Behavioral: Progressive relaxation exercises

No Intervention: Standard care group

NO INTERVENTION

Standard care group.

Interventions

Progressive relaxation exercises BEHAVIORAL

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.

Intervention group: Progressive relaxation exercises

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova Unıversity

Adana, 01260, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 24699796 BACKGROUND

• 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.

  PMID: 24965313 BACKGROUND

MeSH Terms

Conditions

Patient Acceptance of Health Care; Anxiety Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Study Officials

• Zehra ÇERÇER, PhD

  Cukurova University

  PRINCIPAL INVESTIGATOR

• Evşen NAZİK, Prof. Dr.

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 19, 2022
• Study Start: August 18, 2022
• Primary Completion: November 21, 2023
• Study Completion: December 30, 2023
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)