Insomnia and Mindfulness Stress Reduction Program

Postmenopausal Symptoms Clinical Trial

Official title:

The Effect of Mindfulness Stress Reduction Program Applied to Postmenopausal Women on Insomnia and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05202054
• Other study ID #: FIRAT UNIVERSTY
• Status: Completed
• Phase: N/A
• Start date: April 3, 2022
• Est. completion date: January 29, 2023

Study information

• Verified date: April 2023
• Source: Firat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Menopause is the longest life stage in a woman's life, in which psychological and social changes are experienced as well as physical changes and some health problems occur. The symptoms of menopause develop due to varying degrees of somatic and psychological changes that occur as a result of the gradual loss of function of the ovaries. One of the most common and disturbing symptoms of menopause is sleep problems. Sleep is seen as an important health variable that affects an individual's quality of life and well-being. The need for sleep is included among the basic care problems by nursing theorists, and sleep-related problems are included as a nursing diagnosis in the nursing literature. In the literature, it has been stated that mindfulness stress reduction program reduces menopausal symptoms. Nurses should have knowledge about menopause and coping methods in the field. Although the number of studies examining the effect of mindfulness stress reduction program on insomnia, which is one of the menopausal complaints, is very few in the literature.

Description:

Menopause is a medical term defined as the absence of menstrual bleeding lasting more than one year in women in a certain period of life. Menopause is the longest life stage in a woman's life, in which psychological and social changes are experienced as well as physical changes and some health problems occur. The symptoms of menopause develop due to varying degrees of somatic and psychological changes that occur as a result of the gradual loss of function of the ovaries. One of the most common and disturbing symptoms of menopause is sleep problems. Sleep is accepted as one of the basic physiological needs of humans, which covers 1/3 of human life and ensures the continuity of health. In addition to productivity and efficiency, sleep positively affects cognitive functions such as memory and concentration and contributes to physical and psychological restoration. Because of these positive effects, sleep is seen as an important health variable that affects an individual's quality of life and well-being. The need for sleep is included among the basic care problems by nursing theorists, and sleep-related problems are included as a nursing diagnosis in the nursing literature. "Discomfort in sleep pattern", which is defined as a condition that causes discomfort in the quality and quantity of the resting pattern or affects the lifestyle, is an important nursing diagnosis that also affects the quality of life and is among the nursing diagnoses determined by NANDA (North American Nursing Diagnosis Association). In order to cope with the problems participan experience in the menopausal period, women seek various pharmacological and non-pharmacological ways. When the studies conducted in recent years are examined, it has been determined that the commonly used complementary alternative therapies reduce the complaints experienced in menopause. One of the complementary alternative therapies is mindfulness. In the literature, it has been stated that mindfulness stress reduction program reduces menopausal symptoms. Nurses should have knowledge about menopause and coping methods in the field. Counseling the individual and the family is among the responsibilities of the nurse. Although the number of studies examining the effect of mindfulness stress reduction program and acupuncture on insomnia, which is one of the menopausal complaints, is very few in the literature. It is thought that this study, which was designed to examine the effect of mindfulness stress reduction program on insomnia and quality of life from menopausal complaints, will provide evidence and bring innovation to nursing profession practices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 29, 2023
• Est. primary completion date: December 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• being able to read and write,
• Not having a period for at least a year,
• Not having any diagnosed psychiatric disease or not using medication,
• Not using or not using hormone replacement therapy.

Exclusion Criteria:

• To have entered menopause with surgical methods,
• Not participating in at least two group programs.

Related Conditions & MeSH terms

• Postmenopausal Symptoms
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• mindfulness stress reduction program
Before the program is implemented, in case women forget, they will be called and reminded of the training time, and they will be invited to the program. The women in the experimental group will be administered 150 minutes of BFSAP once a week, lasting 8 weeks, and consisting of 8 times in total. Afterwards, the women will be given an intermediate test. After the midterm test, women will be asked to individually repeat their BFSAP administration in their own home for 8 weeks (weeks 8-16).

Locations

Country	Name	City	State
Turkey	NURDILAN	Elazig

Sponsors (1)

Lead Sponsor	Collaborator
NURDILAN SENER

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	women's health initiative insomnia scale	Levine et al. (2003) the validity and reliability study of the scale in our country was done by Timur and Sahin (2009). The scale is a Likert type scale consisting of 5 questions. In the study of Timur and Sahin (2009), the Cronbach Alpha value was found to be 0.85.	UP TO 16 WEEKS
Secondary	Menopause-Specific Quality of Life Scale	The scale was developed by Hilditch et al. in 1996 to measure menopause-specific quality of life. It was adapted to Turkish society by Kharbouch and Sahin in 2005 and its validity and reliability were determined. The scale is a 7-point Likert type scale consisting of 29 questions.; Each sub-domain score was scored from 0 to 6 in the MCQC. "0" points that there is no problem with that issue. A score of "1" indicates that the problem exists, but this problem is not disturbing at all, while scores between 2-6 indicate the severity and increasing levels of the existing problem. The lowest score that can be obtained from the scale is 0, the highest score is 174. The scale consists of four sub-dimensions: vasomotor, psychosocial, physical and sexual. As the score increases, the severity of the complaint increases and the quality of life decreases.	up to 16 weeks