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Pelvic Examination Fear and Education ([pelvicfear])

Primary Purpose

Pelvic Pain, Pelvic Floor; Relaxation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Multimedia education video
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pelvic Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

-Reject to participate to the study

Sites / Locations

  • Alime Buyuk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education Group

Control Group

Arm Description

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).

Women were not given information about vaginal examination in the control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 12, 2021
Last Updated
July 20, 2021
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04983381
Brief Title
Pelvic Examination Fear and Education
Acronym
[pelvicfear]
Official Title
The Effect of Patient Information Training on Anxiety of Gynecologic Examination
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
May 21, 2019 (Actual)
Study Completion Date
May 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Pelvic Floor; Relaxation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Women were not given information about vaginal examination in the control group
Intervention Type
Other
Intervention Name(s)
Multimedia education video
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pelvic Examination of Anxiety
Description
Fear about pelvic exam will be measured with Visual Analog Scale (VAS) 0 shows no fear 10 shows the most fear
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: -Reject to participate to the study
Facility Information:
Facility Name
Alime Buyuk
City
Konyaaltı
State/Province
Antalya
ZIP/Postal Code
07070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Pelvic Examination Fear and Education

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