Pelvic Pain[pelvicfear]NCT04983381
Pelvic Examination Fear and Education
A study testing Multimedia education video in people with Pelvic Pain and Pelvic Floor; Relaxation, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: Gynecologic examination has been a concern for women. The aim of this study is to evaluate the effect of multimedia education on the fear of gynecologic examination. Material and Methods: This randomized controlled study will conducted with 80 voluntary patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Pelvic Floor; Relaxation
- What is being tested?
- Multimedia education video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2018to 21 May 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must not have any known cerebrovascular disease,
- Must not being morbidly obese
- Must not have any heart diseases that would pose an obstacle to the study,
- Must not have any cognitive disorder that would pose an obstacle to communication,
- Must not have any stroke and the associated influence,
- Must agree to participate in the study
Who cannot join
- -Reject to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Patient Information Training on Anxiety of Gynecologic Examination
Objectives: Gynecologic examination has been a concern for women. The aim of this study is to evaluate the effect of multimedia education on the fear of gynecologic examination.
Material and Methods: This randomized controlled study will conducted with 80 voluntary patients. Participants will grouped as training group and control group. The multimedia-based information about vaginal examination is a video based patient education program. The anxiety levels/ scores of the patients will be assessed using the State-Trait Anxiety Inventory (STAI-S [state], STAI-T [trait]) and the Visual Analog Scale (VAS). The entire evaluation will be repeated before and after the examination.
Read the detailed description
The pelvic examination has been a worrisome examination for women since the initial years of gynecology science until today. Intense anxieties experienced by the patients during this examination include primarily, shame and fear of pain or pathology. Reasons such as lack of information about the gynecologic examination, previously established myths by the patient, the speculum being cold, the doctor's attitude, and the position of the examination are also among the reasons why the woman during the examination experienced anxiety. The form of gynecologic examination has varied to a large extent to this day and the examination has begun to be performed in the lithotomy position upon the invention of gynecologic examination tables. It is important that the gynecologist informs patients about the vaginal examination to be performed in this position or healthcare professionals provide short training to them. Information training typically involves the explanation of the vaginal examination and of the pelvic anatomy. The training is aimed to provide relaxation and render the examination more comfortable by explaining pelvic anatomy and pelvic floor muscles. It has been observed that these training which is provided before the interview form pelvic floor relaxation and cause less pain in the patient during the vaginal examination. Patients receiving proper and adequate training are able to understand their own complaints better and manage their disease/examination better. Patient training reduces anxiety and helps to create a more comfortable examination environment.
Previous studies have discussed patient anxieties experienced during interventions such as radiological imaging, endoscopy, colonoscopy, bronchoscopy, and invasive cardiac interventions. Short informative videos that do not cause any cost loss or harm, increase the tolerance with these applications and reduce patient anxiety. Additionally, many studies have emphasized that doctors have no time to provide information training for the vaginal examination while conducting their intense practices. Information that cannot be provided before the gynecologic examination due to limited time causes pelvic pain in women due to the anxiety experienced during the examination. The concept of chronic pelvic pain is defined as a non-cyclical pain that lasts longer than six months and develops in the pelvis and the area below the umbilicus and between the gluteal lines. Pelvic pain is observed depending on the excessive activity of pelvic floor muscles during the examination in patients who have a fear of the gynecologic examination.
The aim of this study is to evaluate the effects of multimedia education provided before the gynecologic examination on the patient's pelvic pain, anxiety, and fear.
- Conditions
- Pelvic Pain, Pelvic Floor; Relaxation
- Being tested
- Multimedia education video
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia education videoOther
The multimedia education video was a 30 minutes information-based patient education program and contained information about pelvic anatomy and how to practice vaginal examination. The same gynecologist (M.S.) (male) who 15 years of experience explained details of vaginal examination, who told about vaginal examination in this video to the study participants, also did the gynecologic examination. The gynecologic examination which contained pelvic ultrasound scan and vaginal examination lasted approximately 20 minutes practice.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | Participants were grouped as; those who were given information about vaginal examination in the training group (n=40) and those who were not given information about vaginal examination in the control group (n=40). Receives: Other: Multimedia education video |
| Control Group | No intervention | Women were not given information about vaginal examination in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Examination of Anxiety
Fear about pelvic exam will be measured with Visual Analog Scale (VAS) 0 shows no fear 10 shows the most fear
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start21 May 2018
- Primary completion21 May 2019
- Study completion21 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alime Buyuk, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983381
- Sponsor's protocol ID
- 2012-KAEK-20-166
- Acronym
- [pelvicfear]
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 30 Jul 2021
- 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 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Information Training on Anxiety of Gynecologic Examination
- ClinicalTrials.gov ID
- NCT04983381
- Acronym / sponsor ID
- [pelvicfear] / 2012-KAEK-20-166
- Conditions
- Pelvic Pain, Pelvic Floor; Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 30 Jul 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.
Objectives: Gynecologic examination has been a concern for women. The aim of this study is to evaluate the effect of multimedia education on the fear of gynecologic examination.
Material and Methods: This randomized controlled study will conducted with 80 voluntary patients. Participants will grouped as training group and control group. The multimedia-based information about vaginal examination is a video based patient education program. The anxiety levels/ scores of the patients will be assessed using the State-Trait Anxiety Inventory (STAI-S [state], STAI-T [trait]) and the Visual Analog Scale (VAS). The entire evaluation will be repeated before and after the examination.
Detailed description
The pelvic examination has been a worrisome examination for women since the initial years of gynecology science until today. Intense anxieties experienced by the patients during this examination include primarily, shame and fear of pain or pathology. Reasons such as lack of information about the gynecologic examination, previously established myths by the patient, the speculum being cold, the doctor's attitude, and the position of the examination are also among the reasons why the woman during the examination experienced anxiety. The form of gynecologic examination has varied to a large extent to this day and the examination has begun to be performed in the lithotomy position upon the invention of gynecologic examination tables. It is important that the gynecologist informs patients about the vaginal examination to be performed in this position or healthcare professionals provide short training to them. Information training typically involves the explanation of the vaginal examination and of the pelvic anatomy. The training is aimed to provide relaxation and render the examination more comfortable by explaining pelvic anatomy and pelvic floor muscles. It has been observed that these training which is provided before the interview form pelvic floor relaxation and cause less pain in the patient during the vaginal examination. Patients receiving proper and adequate training are able to understand their own complaints better and manage their disease/examination better. Patient training reduces anxiety and helps to create a more comfortable examination environment.
Previous studies have discussed patient anxieties experienced during interventions such as radiological imaging, endoscopy, colonoscopy, bronchoscopy, and invasive cardiac interventions. Short informative videos that do not cause any cost loss or harm, increase the tolerance with these applications and reduce patient anxiety. Additionally, many studies have emphasized that doctors have no time to provide information training for the vaginal examination while conducting their intense practices. Information that cannot be provided before the gynecologic examination due to limited time causes pelvic pain in women due to the anxiety experienced during the examination. The concept of chronic pelvic pain is defined as a non-cyclical pain that lasts longer than six months and develops in the pelvis and the area below the umbilicus and between the gluteal lines. Pelvic pain is observed depending on the excessive activity of pelvic floor muscles during the examination in patients who have a fear of the gynecologic examination.
The aim of this study is to evaluate the effects of multimedia education provided before the gynecologic examination on the patient's pelvic pain, anxiety, and fear.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Other: Multimedia education videoParticipants were grouped as; those who were given information about vaginal examination in the training group (n=40) and those who were not given information about vaginal examination in the control group (n=40). |
| Control Group | No intervention | –Women were not given information about vaginal examination in the control group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must not have any known cerebrovascular disease,
- Must not being morbidly obese
- Must not have any heart diseases that would pose an obstacle to the study,
- Must not have any cognitive disorder that would pose an obstacle to communication,
- Must not have any stroke and the associated influence,
Key exclusion criteria (1 listed)
- -Reject to participate to the study
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 |
|---|---|---|
| Multimedia education videoThe multimedia education video was a 30 minutes information-based patient education program and contained information about pelvic anatomy and how to practice vaginal examination. The same gynecologist (M.S.) (male) who 15 years of experience explained details of vaginal examination, who told about vaginal examination in this video to the study participants, also did the gynecologic examination. The gynecologic examination which contained pelvic ultrasound scan and vaginal examination lasted approximately 20 minutes practice. | Other | Education Group |
Primary outcome
Pelvic Examination of Anxiety
Time frame: 6 months
Fear about pelvic exam will be measured with Visual Analog Scale (VAS) 0 shows no fear 10 shows the most fear
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 Jul 2021.
- 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 Multimedia education video in people with Pelvic Pain and Pelvic Floor; Relaxation, run by Akdeniz 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 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 Jul 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?
Pelvic Examination of Anxiety (time frame: 6 months). 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 Jul 2021.