Occupational TherapyNCT04776200
Classical Ballet Dance as a Recreational Activity for Adults Women
An observational study of Occupational Therapy, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Classical ballet dance has just used therapeutically in recent years and can be a good recreational activity option at occupational therapy. The purpose of this study was to investigate whether participation in classical ballet dance activity for at least 3 months is associated with psychological distress, depression… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Occupational Therapy
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 5 Mar 2020
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Accepts Healthy Volunteers
Who may be able to join
- The ballet group's inclusion criteria
- age between 18 and 65 years,
- weekly attendance at ballet classes for at least 3 months
- The control group's inclusion criteria
- age between 18 and 65 years,
- did not participate in any ballet activity.
Who cannot join
- Being a professional dancer or athlete
- Diagnosed with systemic diseases such as rheumatoid arthritis, diabetes
- Diagnosed with psychiatric disorders such as depression, anxiety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health Status of Women Who Attending Classical Ballet Dance
Classical ballet dance has just used therapeutically in recent years and can be a good recreational activity option at occupational therapy. The purpose of this study was to investigate whether participation in classical ballet dance activity for at least 3 months is associated with psychological distress, depression, anxiety, and well-being.
Read the detailed description
A total of 128 adults participated in the study, sixty-four for Ballet Group (BG) and Control Group (CG). The psychological distress of the participants were evaluated with the Distress Tolerance Scale (DTS), anxiety and depression evaluated with Hospital Anxiety and Depression Scale (HADS), and well-being and quality of life evaluated with the World Health Organization Well-Being Index (WHO-5).
- Conditions
- Occupational Therapy
- Keywords
- Dancing, occupational therapy, mental health, adults
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ballet Groups | It was invited the individuals, who were ongoing for at least 3 months in classical ballet dance activity in the dance studio, between December 2019 and March 2020. | |
| Control Groups | It was invited the individuals, who have just registered for classical ballet dance activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The World Health Organisation's Five Well-Being Index
The World Health Organisation's Five Well-Being Index (WHO-5), which is developed by Bench et al., is a valid instrument for the psychometric evaluation of emotional well-being, and quality of life for the previous two weeks (Bech et al., 1996). This measure consists of 5-items, which respondents rated on a scale of "0- never" to "5- all the time". The WHO-5 low score "0" representing the worst possible well-being and "100" the best. The score of lower than 13 could be regarded as indicates poor quality of life.
Measured: 5 minutes. Each participant who meets the inclusion criteria was asked to fill out the form only once in beginning of the study.
Secondary outcomes (2)
The Distress Tolerance Scale
The Distress Tolerance Scale (DTS) is a 15- item, self-report used to assess psychological distress, which is developed by Simons and Gaher (Simons and Gaher, 2005).DTS was used as a function of the time period during which these data were collected. While the original scale has 4 factors Turkish version has 3 factors across Tolerance, Regulation, Self-Efficacy. 5-point Likert-type scale score changes between 1 strongly agree and 5 strongly disagree. The higher scores indicating higher psychological distress tolerance.
Measured: 7 minutes.Each participant who meets the inclusion criteria was asked to fill out the form only once in beginning of the study.
The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS), which is developed by Zigmond et. all is a self-assessment tool for to use of detecting depression and anxiety (Zigmond and Snaith, 1983). HADS investigates how people have felt in the past week. It has included 14- items, which rated on a four-point scale and scored from 0-3, and two subscales, as anxiety (7 items) and depression (7 items), each part scores ranged from 0 to 21. Scores between 0 and 7 indicate normal emotional stated, and higher than 7 on the subscales of the HADS indicated anxiety and depressive disorder.
Measured: 10 minutes. Each participant who meets the inclusion criteria was asked to fill out the form only once in beginning of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jan 2020
- Primary completion1 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Occupational TherapyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZEYNEP BAHADIR AGCE, Uskudar University
- Investigators
- ZEYNEP BAHADIR AGCE, PHD, Study director, occupational therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776200
- Sponsor's protocol ID
- 61351342/2020-135
- Status last verified
- Apr 2021
- First submitted
- 20 Feb 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
da Costa ALB. (2012) Circle dance, occupational therapy and wellbeing: the need for research. British Journal of Occupational Therapy 75: 114-116.
Houston S and McGill A. (2011) English National Ballet dance for Parkinson's: An investigative study. Report retrieved from: http://www. ballet. org. uk/media/filer_public/2015/08/20/english_ national _ballet_dance_ for_parkinsons_an_investigative_study. pdf on 6: 2016
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Status of Women Who Attending Classical Ballet Dance
- ClinicalTrials.gov ID
- NCT04776200
- Acronym / sponsor ID
- 61351342/2020-135
- Conditions
- Occupational Therapy
- Keywords
- Dancing, occupational therapy, mental health, adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 1 Mar 2021 (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.
Classical ballet dance has just used therapeutically in recent years and can be a good recreational activity option at occupational therapy. The purpose of this study was to investigate whether participation in classical ballet dance activity for at least 3 months is associated with psychological distress, depression, anxiety, and well-being.
Detailed description
A total of 128 adults participated in the study, sixty-four for Ballet Group (BG) and Control Group (CG). The psychological distress of the participants were evaluated with the Distress Tolerance Scale (DTS), anxiety and depression evaluated with Hospital Anxiety and Depression Scale (HADS), and well-being and quality of life evaluated with the World Health Organization Well-Being Index (WHO-5).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ballet Groups | – | –It was invited the individuals, who were ongoing for at least 3 months in classical ballet dance activity in the dance studio, between December 2019 and March 2020. |
| Control Groups | – | –It was invited the individuals, who have just registered for classical ballet dance activity. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Accepts Healthy Volunteers
Key inclusion criteria (6 listed)
- The ballet group's inclusion criteria
- age between 18 and 65 years,
- weekly attendance at ballet classes for at least 3 months
- The control group's inclusion criteria
- age between 18 and 65 years,
Key exclusion criteria (3 listed)
- Being a professional dancer or athlete
- Diagnosed with systemic diseases such as rheumatoid arthritis, diabetes
- Diagnosed with psychiatric disorders such as depression, anxiety
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
The World Health Organisation's Five Well-Being Index
Time frame: 5 minutes. Each participant who meets the inclusion criteria was asked to fill out the form only once in beginning of the study.
The World Health Organisation's Five Well-Being Index (WHO-5), which is developed by Bench et al., is a valid instrument for the psychometric evaluation of emotional well-being, and quality of life for the previous two weeks (Bech et al., 1996). This measure consists of 5-items, which respondents rated on a scale of "0- never" to "5- all the time". The WHO-5 low score "0" representing the worst possible well-being and "100" the best. The score of lower than 13 could be regarded as indicates poor quality of life.
2 secondary outcomes
The Distress Tolerance Scale
Time frame: 7 minutes.Each participant who meets the inclusion criteria was asked to fill out the form only once in beginning of the study.
The Hospital Anxiety and Depression Scale
Time frame: 10 minutes. Each participant who meets the inclusion criteria was asked to fill out the form only once in beginning of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Backgroundda Costa ALB. (2012) Circle dance, occupational therapy and wellbeing: the need for research. British Journal of Occupational Therapy 75: 114-116.
- BackgroundHouston S and McGill A. (2011) English National Ballet dance for Parkinson's: An investigative study. Report retrieved from: http://www. ballet. org. uk/media/filer_public/2015/08/20/english_ national _ballet_dance_ for_parkinsons_an_investigative_study. pdf on 6: 2016
- Individual participant dataSharing planned: No
Related trials for Occupational Therapy
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
Not yet recruiting
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
Subjective Cognitive Complaints, Ehlers-Danlos Syndrome
Recruiting
Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities
Disabilities Physical, Falls
Active, not recruiting
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Stress, Psychological, Occupational, Stress, Psychological
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.
ZEYNEP BAHADIR AGCE, PHD study director
occupational therapy
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 Occupational Therapy, run by Uskudar University 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 28 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The World Health Organisation's Five Well-Being Index (time frame: 5 minutes. Each participant who meets the inclusion criteria was asked to fill out the form only once in beginning of the study.). 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 NCT04776200, which also lists 2 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 28 Apr 2021.