AgingNCT06206057
The Relationship Between Leisure Activities and Aging Anxiety in Women
An observational study of Aging and Anxiety, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the effect of leisure activities on aging anxiety of middle-aged (45-59) women. The main question it aims to answer is: Do the leisure activities (doing sports, playing music instruments, doing handicrafts, writing, taking care of a pet, growing plants, dancing… Read more about this study
- Who is it for?
- Ages 45 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Anxiety, Premenopause
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women aged between 40 and 59 registered at the Marmara University Education Family Health Center (FHC) in the Tuzla district
Who may be able to join
- Not having a medical condition that requires urgent intervention or hospitalization
- Not having psychological or physical barrier preventing communication.
Who cannot join
- a medical condition that requires urgent intervention or hospitalization
- having a psychological or physical barrier preventing communication.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Education Family Healthcare Center
Istanbul, Tuzla
About this study
Official title: The Relationship Between Leisure Activities and Aging Anxiety in Middle-aged Women
The goal of this observational study is to learn about the effect of leisure activities on aging anxiety of middle-aged (45-59) women. The main question it aims to answer is: Do the leisure activities (doing sports, playing music instruments, doing handicrafts, writing, taking care of a pet, growing plants, dancing etc.) affect the aging anxiety level of middle-aged women? Participants will be required to fill out a form querying their socio-demographic information, medical histories, and regular leisure activities. Subsequently, the "Aging Anxiety Scale for Middle-Aged Women" will be applied.
Read the detailed description
In this study, women aged between 40 and 59 registered at the Marmara University Education Family Health Center (FHC) in the Tuzla district will be included. There are a total of 352 women in this age range registered with the FHC, and it is aimed to reach all of them.
Patients will be informed about the study by Dr. Buğu Usanma Koban via telephone, and they will be invited to the FHC for the administration of the questionnaire. After obtaining informed consent from those who agree to participate in the study, their personal information will be recorded through a face-to-face interview. Subsequently, the Aging Anxiety Scale for Middle-Aged Women, developed by Lee and You, and validated in Turkish by Aydın and Kabasakal, will be applied to the participants.
Finally, volunteers will be asked to fill out a questionnaire specifying the types and frequencies of their leisure activities. SPSS (version 20.0, SPSS Inc., Chicago, IL, USA) will be used for data analysis.
Descriptive statistical information will be presented as mean ± standard deviation or %, and a p-value less than 0.05 will be considered statistically significant. In the comparison of more than two independent groups that do not meet the assumptions of parametric tests, the Kruskal-Wallis analysis will be conducted. If the analysis is significant, groups will be subjected to pairwise Mann-Whitney U tests.
To understand the relationship between leisure activities and aging anxiety, Spearman Correlation Analysis will be conducted for parameters conforming to normal distribution, and Pearson Correlation Analysis will be performed for parameters not conforming to normal distribution. The correlation coefficient (r value) will be specified.
- Conditions
- Aging, Anxiety, Premenopause, Womans Health
- Keywords
- aging, women's health, anxiety, leisure activities
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of leisure activities on aging anxiety
Relationship between leisure activities' type and frequency, and scores of Aging Anxiety Scale for Middle-Aged Women will be investigated.
The scale consists of 19 questions and is scored on a 5-point Likert scale. The highest possible score on the scale is 95, and the lowest score is 19. Obtaining a high score indicates a high level of aging anxiety.
Measured: 3 months
Secondary outcomes (2)
Sociodemographic properties and aging anxiety
In the form created for collecting sociodemographic information, marital status (married, single, widowed/divorced) and educational status (illiterate, literate, primary school graduate, high school graduate, university and college graduate) will be queried. The correlation between the answers and the scores on the "Aging Anxiety Scale for Middle-Aged Women" will be examined.
The scale consists of 19 questions and is scored on a 5-point Likert scale. The highest possible score on the scale is 95, and the lowest score is 19. Obtaining a high score indicates a high level of aging anxiety.
Measured: 3 months
Effect of chronic diseases on aging anxiety
Correlation between number and type of chronic diseases and the scores on the "Aging Anxiety Scale for Middle-Aged Women" will be examined.
The scale consists of 19 questions and is scored on a 5-point Likert scale. The highest possible score on the scale is 95, and the lowest score is 19. Obtaining a high score indicates a high level of aging anxiety.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buğu Usanma Koban, Marmara University Pendik Training and Research Hospital
- Investigators
- Buğu Usanma Koban, Asst Dr, Principal investigator, Marmara University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206057
- Sponsor's protocol ID
- 09.2023.1457
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barrett AE, Robbins C. The multiple sources of women's aging anxiety and their relationship with psychological distress. J Aging Health. 2008 Feb;20(1):32-65. doi: 10.1177/0898264307309932. Epub 2007 Dec 18.
PubMed 18089765Barrett AE, Toothman EL. Multiple "Old Ages": The Influence of Social Context on Women's Aging Anxiety. J Gerontol B Psychol Sci Soc Sci. 2018 Oct 10;73(8):e154-e164. doi: 10.1093/geronb/gbx027.
PubMed 28453655Oh A, Kim J, Yi E, Shin J. Verification of the Mediating Effect of Social Support on Physical Activity and Aging Anxiety of Korean Pre-Older Adults. Int J Environ Res Public Health. 2020 Nov 2;17(21):8069. doi: 10.3390/ijerph17218069.
PubMed 33147775
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Leisure Activities and Aging Anxiety in Middle-aged Women
- ClinicalTrials.gov ID
- NCT06206057
- Acronym / sponsor ID
- 09.2023.1457
- Conditions
- Aging, Anxiety, Premenopause, Womans Health
- Keywords
- aging, women's health, anxiety, leisure activities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 16 Jan 2024 (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.
The goal of this observational study is to learn about the effect of leisure activities on aging anxiety of middle-aged (45-59) women. The main question it aims to answer is: Do the leisure activities (doing sports, playing music instruments, doing handicrafts, writing, taking care of a pet, growing plants, dancing etc.) affect the aging anxiety level of middle-aged women? Participants will be required to fill out a form querying their socio-demographic information, medical histories, and regular leisure activities. Subsequently, the "Aging Anxiety Scale for Middle-Aged Women" will be applied.
Detailed description
In this study, women aged between 40 and 59 registered at the Marmara University Education Family Health Center (FHC) in the Tuzla district will be included. There are a total of 352 women in this age range registered with the FHC, and it is aimed to reach all of them.
Patients will be informed about the study by Dr. Buğu Usanma Koban via telephone, and they will be invited to the FHC for the administration of the questionnaire. After obtaining informed consent from those who agree to participate in the study, their personal information will be recorded through a face-to-face interview. Subsequently, the Aging Anxiety Scale for Middle-Aged Women, developed by Lee and You, and validated in Turkish by Aydın and Kabasakal, will be applied to the participants.
Finally, volunteers will be asked to fill out a questionnaire specifying the types and frequencies of their leisure activities. SPSS (version 20.0, SPSS Inc., Chicago, IL, USA) will be used for data analysis.
Descriptive statistical information will be presented as mean ± standard deviation or %, and a p-value less than 0.05 will be considered statistically significant. In the comparison of more than two independent groups that do not meet the assumptions of parametric tests, the Kruskal-Wallis analysis will be conducted. If the analysis is significant, groups will be subjected to pairwise Mann-Whitney U tests.
To understand the relationship between leisure activities and aging anxiety, Spearman Correlation Analysis will be conducted for parameters conforming to normal distribution, and Pearson Correlation Analysis will be performed for parameters not conforming to normal distribution. The correlation coefficient (r value) will be specified.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged between 40 and 59 registered at the Marmara University Education Family Health Center (FHC) in the Tuzla district
Key inclusion criteria (2 listed)
- Not having a medical condition that requires urgent intervention or hospitalization
- Not having psychological or physical barrier preventing communication.
Key exclusion criteria (2 listed)
- a medical condition that requires urgent intervention or hospitalization
- having a psychological or physical barrier preventing communication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of leisure activities on aging anxiety
Time frame: 3 months
Relationship between leisure activities' type and frequency, and scores of Aging Anxiety Scale for Middle-Aged Women will be investigated. The scale consists of 19 questions and is scored on a 5-point Likert scale. The highest possible score on the scale is 95, and the lowest score is 19. Obtaining a high score indicates a high level of aging anxiety.
2 secondary outcomes
Sociodemographic properties and aging anxiety
Time frame: 3 months
Effect of chronic diseases on aging anxiety
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 18089765Barrett AE, Robbins C. The multiple sources of women's aging anxiety and their relationship with psychological distress. J Aging Health. 2008 Feb;20(1):32-65. doi: 10.1177/0898264307309932. Epub 2007 Dec 18.
- Background: PubMed 28453655Barrett AE, Toothman EL. Multiple "Old Ages": The Influence of Social Context on Women's Aging Anxiety. J Gerontol B Psychol Sci Soc Sci. 2018 Oct 10;73(8):e154-e164. doi: 10.1093/geronb/gbx027.
- Background: PubMed 33147775Oh A, Kim J, Yi E, Shin J. Verification of the Mediating Effect of Social Support on Physical Activity and Aging Anxiety of Korean Pre-Older Adults. Int J Environ Res Public Health. 2020 Nov 2;17(21):8069. doi: 10.3390/ijerph17218069.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Buğu Usanma Koban, Asst Dr principal investigator
Marmara University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Anxiety, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Buğu Usanma Koban, Asst Dr (00905062041996, buguukoban@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of leisure activities on aging anxiety (time frame: 3 months). 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 NCT06206057, which also lists 3 linked publications.
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 13 Mar 2024.