Perımenopausal Women's Attıtudes Towards Menopause and Spırıtual Well-Beıng

Menopause Clinical Trial

Official title:

The Effect of The Menopause Adaptatıon Program Developed Based on Meleıs' Transıtıon Theory, on The Attıtudes Towards Menopause And Spırıtual Well-Beıng of Perımenopusal Women

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06175962
• Other study ID #: SINOPUakufaci
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: Sinop University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Menopause; cessation of menstruation due to cessation of follicular activity is the transition from the reproductive period to non-reproductive life. Considering that the average life expectancy is increasing, women spend most of their lives in the menopausal period. Women who have a positive attitude towards menopause have a positive body image, experience less depressive experiences, and the severity of menopause symptoms decreases. It has also been assumed that spiritual well-being is effective in reducing the severity of menopause symptoms and anxiety, supporting positive body image, and coping with losses. Baduanjin exercise is a type of body mind exercise. It increases the production of life energy and distributes it to different aspects of the body. It is thought that the baduanjin body-mind exercise to be applied to perimenopausal women will have positive effects on the spiritual well-being of menopausal women and their attitudes towards menopause. Thus, it is expected that women's transition and adaptation to the menopause process will be easier.

Description:

This study will be carried out as a pre-test - post-test randomized controlled experimental study. The population of the research consists of female patients between the ages of 45-55 who are registered to a family health center located in a provincial center in the north of Turkey. Women who are in the perimenopausal period and meet the inclusion criteria according to the Staging of Reproductive Aging in Women (STRAW) criteria will be included in the study. The random.org program will be used to unbiasedly assign 60 women who meet the research criteria to the experimental and control groups. The menopause adaptation program will be applied to the intervention regimen. This program, which will be applied to the experimental group, was prepared based on the Meleisin Transition theory. Since women's menopause is a transition process, the transition theory was preferred. Within the scope of the program, the experimental group will be given online menopause health education for the first 6 weeks and baduanjin exercise will be taught. For the next 8 weeks, individuals will be asked to practice the baduanjin exercise 3 times a week. Online consultation will be provided during this period. The study will be completed in 14 weeks in total. No intervention will be applied to the control group. The study will be terminated after the post-test data is collected. Data will be collected using the Introductory Information Form, the Attitudes Towards Menopause Scale (MITÖ, Spirituality Index of Well-Being Scale).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: August 30, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

Inclusion Criteria:

• Being in the perimenopausal period
• Being between the ages of 40-55
• Having entered menopause naturally
• Volunteering to participate in research

Exclusion Criteria:

• Having a physical problem that prevents exercise
• Being on hormone therapy
• Not having a menstrual period for more than 8 months
• Not using a smartphone

Related Conditions & MeSH terms

• Activity, Motor
• Attitude
• Menopause

Intervention

Behavioral:
• TRAINING AND EXERCISE
Menopause health training will take place in 2 sessions each week and will be completed in 4 sessions. Each session duration is 45 minutes. Baduanjin exercise training will take place in 2 sessions per week, each session lasting 30 minutes. It will be completed in 8 sessions in total. Relaxing music will be played during the Baduanjin exercise and relaxation will be encouraged. During the Baduanjin exercise, proper posture, conscious breathing and focus of the mind will be prioritized. While the movements are being implemented, their symbolic meanings will be explained to the participants. Women will be asked to perform baduanji 3 times a week for 8 weeks. During this process, reminder messages will be sent to women via WhatsApp.

Locations

Country	Name	City	State
Turkey	Aynur ATAMAN KUFACI	Sinop

Sponsors (1)

Lead Sponsor	Collaborator
Sinop University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attitude Scale towards Menopause (MITÖ)	It was developed by Uçanok (1994) to measure the attitudes of women in different age groups towards menopause and its aftermath. There are a total of 20 statements in the scale, 2 positive and 18 negative. The scale is a four-point Likert type. For negative expressions, scoring is done in the opposite direction. The lowest score that can be obtained from the scale is 0 and the highest score is 80. It is accepted that the higher the scores above the average score of 40, the more positive the attitude.	14 WEEKS
Secondary	Spirituality Index of Well-Being Scale	Keskinoglu et al. (2019) conducted the Turkish validity and reliability study of the scale developed by Daaleman and Frey (2004). The scale is a 5-point Likert type consisting of 2 sub-dimensions and 12 items. All items of the scale, which have sub-dimensions of self-efficacy 1, 2, 3, 4, 5, 6 (6 items) and Life schema 7, 8, 9, 10, 11, 12 (6 items), were prepared in reverse and scored in reverse. A high score from each sub-dimension of the scale shows that the individual has the characteristic evaluated by the relevant sub-dimension. The scale also gives a total well-being score. An increase in the scale score indicates an increase in spiritual well-being. When scoring the scale, the average of the sub-dimensions and the total score is taken.	14 WEEKS