Determination of the Effects of Autogenic Relaxation Exercise and Cold Pillow Application on Vasomotor Symptom Control and Quality of Life in Postmenopausal Women

NCT05850338 | Completed

• 1 other identifier: AGunes
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the effect of autogenic relaxation exercise and cold pillows on vasomotor symptom control and quality of life. This randomized controlled study was carried out at Kirikkale University Faculty of Medicine Hospital, Department of Obstetrics and Gynecology, Gynecology Department between 22.06.2018 and 02.01.2019. The sample of the study consisted of 88 people, 44 in the intervention group and 44 in the control group. Since there were case losses in the research, the research was completed with a total of 69 people, 34 in the intervention group and 35 in the control group. The women in the intervention group performed autogenic relaxation exercises and cold pillow application for 8 weeks, and the women in the control group received outpatient care in the hospital. Research data were collected using Descriptive Characteristics Form, Menopause-Specific Quality of Life Scale, Vasomotor Symptom and Practice Follow-up Diary. Data collection tools were applied to the women during the first interview, and at the 4th and 8th weeks after the women were included in the study. In the analysis of descriptive data; number, percentage, mean and standard deviation were used. Independent groups t test was used to determine the difference between groups. The relationship between two independent categorical variables was analyzed using the chi-square test. Variables between dependent groups were compared in repeated measurements with anova test and mixed anova test

Conditions

Vasomotor Symptoms; Quality of Life

Keywords

vasomotor symptoms, quality of life

Outcome Measures

Primary Outcomes (1)

• frequency of vasomotor symptoms number

  vasomotor symptoms experienced per day

  eight weeks

Secondary Outcomes (1)

• vasomotor symptom duration

  eight weeks

Other Outcomes (2)

• vasomotor symptom severity

  eight weeks

• menopause-specific quality of life

  eight weeks

Study Arms (2)

Experimental

EXPERIMENTAL

the autogenic relaxation exercise would be performed to intervention group. In the first interview, the introductory characteristics form was filled and the Menopause Specific Quality of Life Scale was completed. In addition, women were given training in line with the training booklet about the menopause period, autogenic relaxation exercise and cold pillow. After the training, autogenic relaxation exercise was taught accompanied by the autogenic relaxation exercise CD. The woman was informed about performing autogenic relaxation exercises 3 times a day and using a cold pillow when she experienced vasomotor symptoms. The autogenic relaxation exercise and cold pad application follow-up chart, which was prepared for the purpose of recording the applications, was given. The women were evaluated by being invited to the hospital at 4 and 8 weeks, and they filled out the Menopause Specific Quality of Life Scale during the follow-ups. The intervention was implemented for 8 weeks.

Device: cold pad pillow; Behavioral: autogenic training

Control

NO INTERVENTION

After the women to be included in the control group were determined, individual interviews were conducted with the women in a separate room for orogenic relaxation. In the first interview, the introductory characteristics form was filled and the Menopause Specific Quality of Life Scale was completed. The women were evaluated by being invited to the hospital at 4 and 8 weeks, and they filled out the Menopause Specific Quality of Life Scale during the follow-ups. The women were followed for 8 weeks. No other intervention was applied to the women other than the standard care they received at the hospital. The women were called every week and their vasomotor symptoms were questioned.

Interventions

cold pad pillow DEVICE

cold pad pillow application when women have vasomotor symptoms for 8 weeks

Experimental

autogenic training BEHAVIORAL

Autogenic relaxation for three times a day for eight weeks

Experimental

Eligibility Criteria

• Age: 45 Years - 59 Years
• Gender Eligibility Details: Postmenopausal women were included in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Experiencing vasomotor symptoms at least twice a day Least literate Living within the borders of Kirikkale province Women who consented to participate in the study

You may not qualify if:

• Those with hyperthyroidism, pheomacrocytoma, carcinoid syndrome, diabetes mellitus, cancer, tuberculosis, and other chronic infections (Since the symptoms in these diseases can mimic vasomotor symptoms or the disease may cause hot flashes)
• Receiving hormone therapy other than estrogen in the last 12 months (as it affects ovarian function and increases the symptoms of hot flashes)
• Receiving antidepressant and anxiolytic treatment regularly in the last 3 months (because these drugs reduce the symptoms of hot flashes)
• Receiving herbal alternative treatment in the last 4 weeks (since these treatments have a prolonged effect)
• Using other alternative and complementary medicine methods (as it may cause errors while evaluating the study results)
• Having a Body Mass Index of 35 and above
• Using Hormone Replacement Therapy
• Women who had a condition that prevented them from using cold pillows (sensory disorder, mental state disorder, circulatory disorder, open wound, cold allergy, hypersensitivity to cold)

Sponsors & Collaborators

• Aylin Güneş: lead

Study Sites (1)

Aylin Gunes

Ankara, Keçi̇ören, 5058455825, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Autogenic Training

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Aylin Gunes, RN, PhD

  Kırıkkale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data of the study were entered by a person other than the researcher. Statistical analysis was performed by a person other than the researcher. Blinding was done during the evaluation of the data. Intervention and control groups were coded as 1 and 2. The analysis of the data coded in terms of groups was made by the statistician. After the statistical analysis, the coding for the intervention and control groups was explained. Statistical bias was controlled by this blanking technique.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asistant Professor

Model Details: A randomised controlled trial

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: June 22, 2018
• Primary Completion: July 22, 2018
• Study Completion: January 2, 2019
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)