Body ImageNCT07344896
MBSR Effects on Aging Anxiety and Body Image
A study testing bilinçli farkındalık temelli stres azaltma programı in people with Body Image and Mindfulness Based Stress Reduction, run by KTO Karatay University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image, Mindfulness Based Stress Reduction, Middle Aged
- What is being tested?
- bilinçli farkındalık temelli stres azaltma programı
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least primary school graduate,
- Being between 40-59 years old,
- Living in Çumra district center,
- Being open to communication and cooperation
Who cannot join
- Those with chronic illnesses (self-report)
- Foreign nationals Those with psychiatric illnesses (self-report) Those with physical disabilities and limited mobility
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Body Image, Mindfulness Based Stress Reduction, Middle Aged
- Being tested
- bilinçli farkındalık temelli stres azaltma programı
- Keywords
- aging anxiety, middle age woman, mindfulness, body image
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilinçli farkındalık temelli stres azaltma programıBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based stress reduction program intervention group | Experimental | After the pre-test, a mindfulness-based stress reduction program will be implemented. It will be evaluated with a post-test. Receives: Behavioral: bilinçli farkındalık temelli stres azaltma programı |
| control group | No intervention | A pre-test will be administered. No practice will be conducted. Students will be evaluated with a post-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aging Anxiety Score as Measured by the Aging Anxiety Scale for Middle-Aged Women
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.
Measured: Baseline and immediately post-intervention (8 weeks)
Secondary outcomes (1)
Change in Body Image Score as Measured by the Body Image Scale
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.
Measured: Baseline and post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, block randomization will be applied. Participants will be stratified based on two variables: menopausal status (yes/no) with two levels, and educational level (literate-primary school / high school / university and above) with three levels. Within each stratum, block randomization will be conducted using variable block sizes (4 and 6) to ensure a 1:1 allocation ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Necibe Ş TUNALI, 1, Study director, KTO KARATAY UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344896
- Sponsor's protocol ID
- Karatay University
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the sensitive nature of the psychological and health-related information collected from middle-aged women. The dataset includes identifiable variables related to aging anxiety, body image, and mindfulness-based intervention outcomes. Sharing such data may pose confidentiality risks despite anonymization efforts. Aggregated results will be available upon request.
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 at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mindfulness-Based Stress Reduction Program on Aging Anxiety and Body Image in Middle-Aged Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07344896
- Acronym / sponsor ID
- Karatay University
- Conditions
- Body Image, Mindfulness Based Stress Reduction, Middle Aged
- Keywords
- aging anxiety, middle age woman, mindfulness, body image
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study, block randomization will be applied. Participants will be stratified based on two variables: menopausal status (yes/no) with two levels, and educational level (literate-primary school / high school / university and above) with three levels. Within each stratum, block randomization will be conducted using variable block sizes (4 and 6) to ensure a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based stress reduction program intervention group | Experimental | Behavioral: bilinçli farkındalık temelli stres azaltma programıAfter the pre-test, a mindfulness-based stress reduction program will be implemented. It will be evaluated with a post-test. |
| control group | No intervention | –A pre-test will be administered. No practice will be conducted. Students will be evaluated with a post-test |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At least primary school graduate,
- Being between 40-59 years old,
- Living in Çumra district center,
- Being open to communication and cooperation
Key exclusion criteria (2 listed)
- Those with chronic illnesses (self-report)
- Foreign nationals Those with psychiatric illnesses (self-report) Those with physical disabilities and limited mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilinçli farkındalık temelli stres azaltma programıFollowing 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. | Behavioural | mindfulness-based stress reduction program intervention group |
Primary outcome
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.
1 secondary outcome
Change in Body Image Score as Measured by the Body Image Scale
Time frame: Baseline and post-intervention (8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- BackgroundAydın, 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
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the sensitive nature of the psychological and health-related information collected from middle-aged women. The dataset includes identifiable variables related to aging anxiety, body image, and mindfulness-based intervention outcomes. Sharing such data may pose confidentiality risks despite anonymization efforts. Aggregated results will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Necibe Ş TUNALI, 1 study director
KTO KARATAY UNİVERSİTY
Questions about this trial
What is this clinical trial studying?
A study testing bilinçli farkındalık temelli stres azaltma programı in people with Body Image and Mindfulness Based Stress Reduction, run by KTO Karatay University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Necibe ş tunalı, master (+90 543 242 0280, necibe.seyda.tunali@karatay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07344896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.