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

Primary Purpose

Family Planning Services, Telemedicine, Pregnant Women

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video call sessions
Sponsored by
Fenerbahce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Family Planning Services focused on measuring Family Planning Services, Telemedicine, Pregnant Women, Women's Health, COVID-19 Pandemic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Fenerbahce University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedicine Practices

Routine Contraceptive Counseling Services

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Primary outcome

Secondary Outcome Measures

Full Information

First Posted
February 22, 2023
Last Updated
February 22, 2023
Sponsor
Fenerbahce University
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1. Study Identification

Unique Protocol Identification Number
NCT05743309
Brief Title
Evaluation of Telemedicine Practices for Contraceptive Counseling During the COVID-19 Pandemic: A Randomized Controlled Trial
Official Title
Evaluation of Telemedicine Practices for Contraceptive Counseling Given to Pregnant Women During the COVID-19 Pandemic: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fenerbahce 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Planning Services, Telemedicine, Pregnant Women, Women's Health, COVID-19 Pandemic
Keywords
Family Planning Services, Telemedicine, Pregnant Women, Women's Health, COVID-19 Pandemic

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Participants did not know which group they were assigned to.
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine Practices
Arm Type
Experimental
Arm Description
In this study, telemedicine practices stand for video call sessions used for contraceptive counseling services.
Arm Title
Routine Contraceptive Counseling Services
Arm Type
No Intervention
Arm Description
Participants in the control group received only routine contraceptive counseling services provided by primary health care settings.
Intervention Type
Behavioral
Intervention Name(s)
Video call sessions
Intervention Description
Investigators made video call sessions with the participants.
Primary Outcome Measure Information:
Title
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.
Description
Primary outcome
Time Frame
6 Months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Fenerbahce University
City
Istanbul
State/Province
Atasehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34400152
Citation
Steenland MW, Geiger CK, Chen L, Rokicki S, Gourevitch RA, Sinaiko AD, Cohen JL. Declines in contraceptive visits in the United States during the COVID-19 pandemic. Contraception. 2021 Dec;104(6):593-599. doi: 10.1016/j.contraception.2021.08.003. Epub 2021 Aug 14.
Results Reference
result
PubMed Identifier
33212033
Citation
Stifani BM, Avila K, Levi EE. Telemedicine for contraceptive counseling: An exploratory survey of US family planning providers following rapid adoption of services during the COVID-19 pandemic. Contraception. 2021 Mar;103(3):157-162. doi: 10.1016/j.contraception.2020.11.006. Epub 2020 Nov 17.
Results Reference
result
PubMed Identifier
32059840
Citation
Martinez KA, Rastogi R, Lipold L, Rothberg MB. Response to requests for contraception in one direct-to-consumer telemedicine service. Contraception. 2020 May;101(5):350-352. doi: 10.1016/j.contraception.2020.01.017. Epub 2020 Feb 12.
Results Reference
result
PubMed Identifier
35594989
Citation
Stifani BM, Madden T, Micks E, Moayedi G, Tarleton J, Benson LS. Society of Family Planning Clinical Recommendations: Contraceptive Care in the Context of Pandemic Response. Contraception. 2022 Sep;113:1-12. doi: 10.1016/j.contraception.2022.05.006. Epub 2022 May 18.
Results Reference
result
PubMed Identifier
36060498
Citation
Huang I, Delay R, Boulware A, McHugh A, Wong ZJ, Whitaker AK, Stulberg D, Hasselbacher L. Telehealth for contraceptive care: Lessons from staff and clinicians for improving implementation and sustainability in Illinois. Contracept X. 2022 Aug 14;4:100083. doi: 10.1016/j.conx.2022.100083. eCollection 2022.
Results Reference
result
PubMed Identifier
33861981
Citation
Stifani BM, Smith A, Avila K, Boos EW, Ng J, Levi EE, Benfield NC. Telemedicine for contraceptive counseling: Patient experiences during the early phase of the COVID-19 pandemic in New York City. Contraception. 2021 Sep;104(3):254-261. doi: 10.1016/j.contraception.2021.04.006. Epub 2021 Apr 20.
Results Reference
result
PubMed Identifier
33599196
Citation
Mickler AK, Carrasco MA, Raney L, Sharma V, May AV, Greaney J. Applications of the High Impact Practices in Family Planning during COVID-19. Sex Reprod Health Matters. 2021 Dec;29(1):1881210. doi: 10.1080/26410397.2021.1881210.
Results Reference
result
PubMed Identifier
35766699
Citation
Karaahmet AY, Bilgic FS. COVID-19: the unmet need for family planning and its effects on sexuality: a cross-sectional study. Rev Assoc Med Bras (1992). 2022 Jun 24;68(6):827-832. doi: 10.1590/1806-9282.20220138. eCollection 2022.
Results Reference
result
PubMed Identifier
34058421
Citation
Miller HE, Henkel A, Leonard SA, Miller SE, Tran L, Bianco K, Shaw KA. The impact of the COVID-19 pandemic on postpartum contraception planning. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100412. doi: 10.1016/j.ajogmf.2021.100412. Epub 2021 May 28.
Results Reference
result
PubMed Identifier
36759838
Citation
Sileo KM, Muhumuza C, Helal T, Olfers A, Lule H, Sekamatte S, Kershaw TS, Wanyenze RK, Kiene SM. Exploring the effects of COVID-19 on family planning: results from a qualitative study in rural Uganda following COVID-19 lockdown. Reprod Health. 2023 Feb 9;20(1):31. doi: 10.1186/s12978-023-01566-3.
Results Reference
result
PubMed Identifier
34483512
Citation
Krishna UR. Reproductive Health During the COVID-19 Pandemic. J Obstet Gynaecol India. 2021 Aug;71(Suppl 1):7-11. doi: 10.1007/s13224-021-01546-2. Epub 2021 Aug 30.
Results Reference
result

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

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