Pelvic Examination Fear and Education

NCT04983381 | Completed

• 1 other identifier: 2012-KAEK-20-166
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Pelvic Floor; Relaxation

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (2)

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).

Other: Multimedia education video

Control Group

NO INTERVENTION

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

Interventions

Multimedia education video OTHER

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.

Education Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Reject to participate to the study

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Alime Buyuk

Konyaalti, Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 30, 2021
• Study Start: May 21, 2018
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2020
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)