Evaluation of Telemedicine Practices for Contraceptive Counseling During the COVID-19 Pandemic: A Randomized Controlled Trial

Sponsor
Fenerbahce University (Other)
Overall Status
Completed
CT.gov ID
NCT05743309
Collaborator
(none)
77
1
2
5.4
14.2

Study Details

Study Description

Brief Summary

The goal of this randomized clinical trial is to evaluate the telemedicine practices for contraceptive counseling given to pregnant women during the COVID-19 pandemic. The main questions it aims to answer are:

  • Does family planning counseling given to pregnant women by using telemedicine practices have an effect on the knowledge level about family planning?

  • Is family planning counseling given to pregnant women by using telemedicine practices effective on satisfaction with family planning services? Participants have attended to contraceptive counseling video call sessions provided via WhatsApp application and they have the opportunity to see the consultant and her materials during these sessions. After these sessions (two weeks later), contraceptive counseling video call session has been repeated, and at the end of this second session, women have been asked to answer the questions in the "Family Planning Knowledge Level Form" and the "Family Planning Services Satisfaction Scale". There is a comparison group (a control group) in this study, and no intervention was made to the women in the control group other than the routine services given in primary care settings.

Researchers will compare the experimental group with control group to see if the telemedicine practices are effective in increasing the knowledge level of pregnant women about family planning and in the satisfaction of family planning services provided by primary health care settings.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Video call sessions
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
In this study, there are two groups (one experimental and one control group). While experimental group patients received telemedicine practices related to Family planning, control group patients received only routine health services provided by primary health care setting.In this study, there are two groups (one experimental and one control group). While experimental group patients received telemedicine practices related to Family planning, control group patients received only routine health services provided by primary health care setting.
Masking:
Single (Participant)
Masking Description:
Participants did not know which group they were assigned to.
Primary Purpose:
Health Services Research
Official Title:
Evaluation of Telemedicine Practices for Contraceptive Counseling Given to Pregnant Women During the COVID-19 Pandemic: A Randomized Controlled Trial
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telemedicine Practices

In this study, telemedicine practices stand for video call sessions used for contraceptive counseling services.

Behavioral: Video call sessions
Investigators made video call sessions with the participants.

No Intervention: Routine Contraceptive Counseling Services

Participants in the control group received only routine contraceptive counseling services provided by primary health care settings.

Outcome Measures

Primary Outcome Measures

  1. Family planning counseling given to pregnant women by using telemedicine practices have an effect on the knowledge level about family planning and on the satisfaction with family planning services. [6 Months]

    Primary outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Women in the third trimester of their pregnancy and who agreed to participate in the study have been included in this study.
Exclusion Criteria:
  • Women with psychiatric disorder have been excluded from this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fenerbahce University Istanbul Atasehir Turkey

Sponsors and Collaborators

  • Fenerbahce University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rabia Saglam Aksut, Asst. Prof., Fenerbahce University
ClinicalTrials.gov Identifier:
NCT05743309
Other Study ID Numbers:
  • FenerbahçeU
First Posted:
Feb 24, 2023
Last Update Posted:
Feb 24, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rabia Saglam Aksut, Asst. Prof., Fenerbahce University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2023