Quality of LifeNCT04164628
Evaluation of Quality of Life in Women
A study testing Quality of life assessment in people with Quality of Life and Women Health, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
300 women will be evaluated in this study. Their quality of life, level of physical activity, Social Functioning, levels of depression and musculoskeletal status will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Women Health, Social Interaction
- What is being tested?
- Quality of life assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2019to 28 Jun 2020
- Phase
- Interventional
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be a volunteer
Who cannot join
- having severe musculoskeletal system disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Affecting Factors Quality of Life in Women
300 women will be evaluated in this study. Their quality of life, level of physical activity, Social Functioning, levels of depression and musculoskeletal status will be assessed.
Read the detailed description
Many factors affects quality of life in women. In the literature, factors affecting the quality of life such as diseases, working conditions and psychological factors of women have been investigated in different diseases. However, there was no study investigating the factors affecting quality of life for a sample of adult female individuals. Therefore, the aim of our study is to investigate the effect of social, psychological and physical variables that we think may affect the quality of life in women.
- Conditions
- Quality of Life, Women Health, Social Interaction
- Being tested
- Quality of life assessment
- Keywords
- quality of life, depression, anxiety, social function
- Medical subject headings
- Depression, Anxiety Disorders, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life assessmentOther
Quality of life will be assessed with Nottingham Health Profile
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: quality of life assessment | Experimental | Women's quality of life will be evaluated. Receives: Other: Quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
The Nottingham Health Profile is a general patient self-evaluation of subjective health status. The score of this questionnaire ranges between 0 and 600. The higher score indicates the worse quality of life.
Measured: 5 minutes
Secondary outcomes (4)
Social Functioning Scale
Questionnaire is specifically designed to assess the most relevant areas of social functioning. The higher score indicates the better social function.
Measured: 10 minutes
Depression scale
The Beck Depression Inventory is a 21-item self-administered scale measuring various symptoms of depression. It comprises 21 groups of statements describing the somatic and cognitive-emotional symptoms of depression. Each item consists of four alternative responses.
graded from 0 to 3 according to the severity of the symptom. The patients choose the response closest to their state during the past week. A sum score is counted, a higher score indicating more severe depression
Measured: 5 minutes
physical activity level
Physical activity was assessed using the self-administered short (7-item) forms of the international physical activity questionnaire. The higher score indicates the more physically active lifestyle.
Measured: 5 minutes
Musculoskeletal status
The Nordic musculoskeletal questionnaire includes 27 items exploring the presence of musculoskeletal symptoms during a 12-month period covering the nine different parts of the body. The higher score indicates the worse musculoskeletal status.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start30 Nov 2019
- Primary completion1 Jun 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Demircioğlu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164628
- Sponsor's protocol ID
- GO 19/1046
- Status last verified
- Jun 2020
- First submitted
- 13 Nov 2019
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Affecting Factors Quality of Life in Women
- ClinicalTrials.gov ID
- NCT04164628
- Acronym / sponsor ID
- GO 19/1046
- Conditions
- Quality of Life, Women Health, Social Interaction
- Keywords
- quality of life, depression, anxiety, social function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 15 Nov 2019 (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.
300 women will be evaluated in this study. Their quality of life, level of physical activity, Social Functioning, levels of depression and musculoskeletal status will be assessed.
Detailed description
Many factors affects quality of life in women. In the literature, factors affecting the quality of life such as diseases, working conditions and psychological factors of women have been investigated in different diseases. However, there was no study investigating the factors affecting quality of life for a sample of adult female individuals. Therefore, the aim of our study is to investigate the effect of social, psychological and physical variables that we think may affect the quality of life in women.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: quality of life assessment | Experimental | Other: Quality of life assessmentWomen's quality of life will be evaluated. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be a volunteer
Key exclusion criteria (1 listed)
- having severe musculoskeletal system disorders
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 |
|---|---|---|
| Quality of life assessmentQuality of life will be assessed with Nottingham Health Profile | Other | Experimental Group: quality of life assessment |
Primary outcome
Quality of life
Time frame: 5 minutes
The Nottingham Health Profile is a general patient self-evaluation of subjective health status. The score of this questionnaire ranges between 0 and 600. The higher score indicates the worse quality of life.
4 secondary outcomes
Social Functioning Scale
Time frame: 10 minutes
Depression scale
Time frame: 5 minutes
physical activity level
Time frame: 5 minutes
Musculoskeletal status
Time frame: 5 minutes
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 30 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life assessment in people with Quality of Life and Women Health, run by Hacettepe 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 1 inclusion and 1 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 30 Jun 2020. 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?
Quality of life (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2020.