- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344896
MBSR Effects on Aging Anxiety and Body Image
Effects of a Mindfulness-Based Stress Reduction Program on Aging Anxiety and Body Image in Middle-Aged Women: A Randomized Controlled Trial
This study was designed to determine the effect of a mindfulness-based stress reduction (MBSR) program on aging anxiety and body image among middle-aged women. The primary hypotheses to be tested are as follows:
H0a: There is no difference in the mean scores of the Aging Anxiety Scale between the women in the experimental group who receive the mindfulness-based stress reduction program and the women in the control group.
H0b: There is no difference in the mean scores of the Body Image Scale between the women in the experimental group who receive the mindfulness-based stress reduction program and the women in the control group.
H0c: There is no difference between the pre-intervention and post-intervention mean scores of the Aging Anxiety Scale among the women in the experimental group who receive the mindfulness-based stress reduction program.
H0d: There is no difference between the pre-intervention and post-intervention mean scores of the Body Image Scale among the women in the experimental group who receive the mindfulness-based stress reduction program.
The researchers will compare the experimental group with the control group in order to assess the effect of the mindfulness-based stress reduction program on aging anxiety and body image among middle-aged women.
Participants:
- They will attend an 8-session mindfulness-based stress reduction program.
- They will participate in one silent mindfulness retreat session.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Necibe ş tunalı, master
- Phone Number: +90 543 242 0280
- Email: necibe.seyda.tunali@karatay.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least primary school graduate,
- Being between 40-59 years old,
- Living in Çumra district center,
- Being open to communication and cooperation
Exclusion Criteria:
- Those with chronic illnesses (self-report)
- Foreign nationals Those with psychiatric illnesses (self-report) Those with physical disabilities and limited mobility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mindfulness-based stress reduction program intervention group
After the pre-test, a mindfulness-based stress reduction program will be implemented.
It will be evaluated with a post-test.
|
Following application to the center, the Mindfulness-Based Stress Reduction (MBSR) program will be implemented starting from the scheduled date. The program will last a total of 8 weeks, with one session per week, each session lasting approximately 2 hours. At the end of the 6th week, one day will be designated as a "day of silence," during which a 6-hour session will be conducted. The 8-week program is structured around the themes of aging anxiety and body image. During the day of silent awareness (after the 6th week), the 6-hour silence period will include body scan practices, mindful walking, and breathing meditation. The aim of this silent retreat day is to deepen participants' internal awareness. |
|
No Intervention: control group
A pre-test will be administered.
No practice will be conducted.
Students will be evaluated with a post-test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Aging Anxiety Score as Measured by the Aging Anxiety Scale for Middle-Aged Women
Time Frame: Baseline and immediately post-intervention (8 weeks)
|
Aging anxiety will be assessed using the Aging Anxiety Scale for Middle-Aged Women, a self-report questionnaire consisting of Likert-type items.
The outcome will be evaluated as the mean change in total scale score from baseline to immediately post-intervention.
Higher scores indicate higher levels of aging anxiety.
|
Baseline and immediately post-intervention (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Image Score as Measured by the Body Image Scale
Time Frame: Baseline and post-intervention (8 weeks)
|
Body image will be assessed using the Body Image Scale, a self-report instrument measuring individuals' perceptions and attitudes toward their own bodies.
The outcome will be evaluated as the mean change in total scale score from baseline to post-intervention.
Higher scores indicate a more positive body image.
|
Baseline and post-intervention (8 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Necibe Ş TUNALI, 1, KTO Karatay University
Publications and helpful links
General Publications
- Aydın, A., & Kabasakal, E. (2022). Turkish adaptation of the Aging Anxiety Scale for middle-aged women: Validity and reliability study. Journal of Basic and Clinical Health Sciences, 6, 173-180. https://doi.org/10.30621/jbachs.2022.1012 Bergman, Y. S., & Segel-Karpas, D. (2018). Future time perspective, loneliness, and depressive symptoms among middle-aged adults: A mediation model. Journal of Affective Disorders, 241, 173-175. https://doi.org/10.1016/j.jad.2018.08.019 Bergman, Y. S., & Segel-Karpas, D. (2021). Aging anxiety, loneliness, and depressive symptoms among middle-aged adults: The moderating role of ageism. Journal of Affective Disorders, 290, 89-92. https://doi.org/10.1016/j.jad.2021.04.077 Cameron, E., Ward, P., Mandville-Anstey, S. A., & Coombs, A. (2018). The female aging body: A systematic review of female perspectives on aging, health, and body image. Journal of Women & Aging, 31(1), 3-17. https://doi.org/10.1080/08952841.2018.1449586 Creswell, J. D. (2017). Mindfulness interventions. Annual Review of Psychology, 68, 491-516. https://doi.org/10.1146/annurev-psych-042716-051139 Fernandez-Jimenez, C., Alvarez-Hernandez, J. F., Salguero-Garcia, D., Aguilar-Parra, J. M., & Trigueros, R. (2020). Validation of the Lasher and Faulkender Anxiety about Aging Scale (AAS) for the Spanish context. International Journal of Environmental Research and Public Health, 17(12), 4231. https://doi.org/10.3390/ijerph17124231 Gendron, T. L., Inker, J. K., Andricosky, R., & Zanjani, F. (2020). Development of the relational ageism scale: Confirmatory test on survey data. International Journal of Aging and Human Development, 90(3), 281-296. https://doi.org/10.1177/0091415019836956 Lee, H., & You, M. (2019). Development of an aging anxiety scale for middle-aged women. Journal of Korean Academy of Nursing, 49(1), 14-25. https://doi.org/10.4040/jkan.2019.49.1.14
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Karatay University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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