GynecologyNCT06324019
Gynaecological Examination Gown and Patient Satisfaction
A study testing putting on an examination gown in people with Gynecology and Gynecology/Obstetrics Conditions, run by ayşegül muslu at 1 site in Turkey (Türkiye).
Trial summary
The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have a significant impact on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecology, Gynecology/Obstetrics Conditions
- What is being tested?
- putting on an examination gown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 22 Jun 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women who will undergo gynaecological examination
- Women who volunteered to participate in the study
- no physical disabilities
Who cannot join
- Women who will not undergo a gynaecological examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Gynecological Examination Dress and Determining Its Effect on Perception of Privacy and Satisfaction: Randomized Controlled Trial
The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have a significant impact on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. The use of different clothes in the patient during the examination will ensure that the patient\'s physical privacy is ensured from the moment of application, during diagnosis and treatment, and that the examination experience will be positively affected by preventing the use of additional covers to protect the privacy of all patients during examination and intervention. This will contribute to the maintenance of health by eliminating the intense stress and embarrassment experienced by patients during the examination and ensuring that they regularly attend health checks. In addition, meeting the privacy expectations of the patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided.
The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have an important effect on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. With the examination suit, it will be ensured that the patient\'s bodily privacy is ensured from the moment of application, during diagnosis, treatment and care, the use of the same cover to protect the privacy of all patients during examination and intervention will be prevented to prevent infection transmission and the examination experience will be positively affected. Thus, the intense stress and embarrassment experienced by patients during the examination will be eliminated and will contribute to the maintenance of health through regular visits to health checks. In addition, meeting the privacy expectations of patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided. In order to ensure patient privacy, to protect and improve women\'s health and to provide convenience in gynecological examination, the gynecological examination garment to be used in the examination can be designed as disposable, perineum and thigh open for the examination to be performed. In order to protect privacy, extra parts can be used to ensure that the open parts remain closed outside the examination process. Properties of the fabric used in the examination garment;
Read more
- Grama: 32,07 g/m^2
- Explosion.: 135,77 kpç
- Detachment: Ȼ: 115NȺ: 120 N
- Air permeability: 1750
- Type of material: Polypropylene
The study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted.
- Conditions
- Gynecology, Gynecology/Obstetrics Conditions
- Being tested
- putting on an examination gown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
putting on an examination gownOther
During the gynecological examination, the patient in the experimental group will be made to wear an examination gown, while the patient in the control group will use the routine practice of the hospital. In this way, with the gynecological examination clothing to be developed, the body privacy of the patients will be protected during the examination. In addition, women will feel less anxiety during gynecological examination and important steps will be taken in maintaining women\'s health by ensuring regular gynecological examination.
| Study group | Role | What they receive |
|---|---|---|
| Developing Gynecological Examination Dress | Experimental | Gown will be put on the patient before gynaecological examination and their satisfaction will be evaluated Receives: Other: putting on an examination gown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gynaecological examination gown
In this study, women's satisfaction with the clothing developed will be evaluated with the Body Privacy in Gynecology and Obstetrics Scale. The scale is a five-point Likert-type scale with thirty-seven items consisting of "General Privacy", "Rights and Privacy", "Ethics and Privacy" and "Clinical Privacy" sub-dimensions. All of the statements in the dimensions are positive and the answers given to each item were summed by scoring between 1-5 and then the mean values were calculated for each item. It is understood that the higher the mean scores obtained from the scale, the more sensitive the participants are about privacy in the relevant area. The General Rights and Privacy Dimension of the scale consists of statements between items 1-9. Rights and privacy dimension consists of statements between items 10-14. Ethical rights and privacy dimension consists of statements between items 15-19. Clinical and privacy dimension consists of statements between items 20-37.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Feb 2022
- Primary completion30 Apr 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecologyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted. Hypotheses of the Study 1. Ho: There is no difference between the perception of privacy in the experimental and control group women. H1: There is a difference between the perception of privacy in the experimental group and control group women. 2. Ho: There is no difference between the perception of satisfaction in the experimental group and control group women. H1: There is a difference between the satisfaction perception of women in the experimental group and the control group.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- ayşegül muslu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ayşegül muslu, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324019
- Sponsor's protocol ID
- Ethics number E.405221
- Status last verified
- Mar 2024
- First submitted
- 8 Feb 2024
- Last updated
- 21 Mar 2024
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Gynecological Examination Dress and Determining Its Effect on Perception of Privacy and Satisfaction: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06324019
- Acronym / sponsor ID
- Ethics number E.405221
- Conditions
- Gynecology, Gynecology/Obstetrics Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- ayşegül musluUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 21 Mar 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 attitude of the health personnel before, during and after the examination and the positive examination experience of the person have a significant impact on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. The use of different clothes in the patient during the examination will ensure that the patient\'s physical privacy is ensured from the moment of application, during diagnosis and treatment, and that the examination experience will be positively affected by preventing the use of additional covers to protect the privacy of all patients during examination and intervention. This will contribute to the maintenance of health by eliminating the intense stress and embarrassment experienced by patients during the examination and ensuring that they regularly attend health checks. In addition, meeting the privacy expectations of the patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided.
The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have an important effect on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. With the examination suit, it will be ensured that the patient\'s bodily privacy is ensured from the moment of application, during diagnosis, treatment and care, the use of the same cover to protect the privacy of all patients during examination and intervention will be prevented to prevent infection transmission and the examination experience will be positively affected. Thus, the intense stress and embarrassment experienced by patients during the examination will be eliminated and will contribute to the maintenance of health through regular visits to health checks. In addition, meeting the privacy expectations of patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided. In order to ensure patient privacy, to protect and improve women\'s health and to provide convenience in gynecological examination, the gynecological examination garment to be used in the examination can be designed as disposable, perineum and thigh open for the examination to be performed. In order to protect privacy, extra parts can be used to ensure that the open parts remain closed outside the examination process. Properties of the fabric used in the examination garment;
- Grama: 32,07 g/m^2
- Explosion.: 135,77 kpç
- Detachment: Ȼ: 115NȺ: 120 N
- Air permeability: 1750
- Type of material: Polypropylene
The study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted. Hypotheses of the Study 1. Ho: There is no difference between the perception of privacy in the experimental and control group women. H1: There is a difference between the perception of privacy in the experimental group and control group women. 2. Ho: There is no difference between the perception of satisfaction in the experimental group and control group women. H1: There is a difference between the satisfaction perception of women in the experimental group and the control group.
| Arm | Type | Receives |
|---|---|---|
| Developing Gynecological Examination Dress | Experimental | Other: putting on an examination gownGown will be put on the patient before gynaecological examination and their satisfaction will be evaluated |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women who will undergo gynaecological examination
- Women who volunteered to participate in the study
- no physical disabilities
Key exclusion criteria (1 listed)
- Women who will not undergo a gynaecological examination
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 |
|---|---|---|
| putting on an examination gownDuring the gynecological examination, the patient in the experimental group will be made to wear an examination gown, while the patient in the control group will use the routine practice of the hospital. In this way, with the gynecological examination clothing to be developed, the body privacy of the patients will be protected during the examination. In addition, women will feel less anxiety during gynecological examination and important steps will be taken in maintaining women\'s health by ensuring regular gynecological examination. | Other | Developing Gynecological Examination Dress |
Primary outcome
Gynaecological examination gown
Time frame: 1 year
In this study, women's satisfaction with the clothing developed will be evaluated with the Body Privacy in Gynecology and Obstetrics Scale. The scale is a five-point Likert-type scale with thirty-seven items consisting of "General Privacy", "Rights and Privacy", "Ethics and Privacy" and "Clinical Privacy" sub-dimensions. All of the statements in the dimensions are positive and the answers given to each item were summed by scoring between 1-5 and then the mean values were calculated for each item. It is understood that the higher the mean scores obtained from the scale, the more sensitive the participants are about privacy in the relevant area. The General Rights and Privacy Dimension of the scale consists of statements between items 1-9. Rights and privacy dimension consists of statements between items 10-14. Ethical rights and privacy dimension consists of statements between items 15-19. Clinical and privacy dimension consists of statements between items 20-37.
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 21 Mar 2024.
- 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 putting on an examination gown in people with Gynecology and Gynecology/Obstetrics Conditions, run by ayşegül muslu 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 3 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 21 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?
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?
Gynaecological examination gown (time frame: 1 year). 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 21 Mar 2024.