Effect of a Social-Support-Based Educational Intervention on COVID-19-Related Anxiety and Perceived Social Support in Pregnant Women: A Randomized Pretest-Posttest Controlled Trial

NCT07856576 | Completed DMC

• 1 other identifier: IR.GMU.REC.1400.071
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to learn if a spouse-inclusive, social-support-based educational intervention can reduce COVID-19-related anxiety and improve perceived social support in pregnant women during public health emergencies. The main questions it aims to answer are:

• Does the intervention reduce COVID-19-related anxiety in pregnant women compared to routine care?
• Does the intervention improve perceived social support across its five dimensions (emotional, informational, tangible, affection, and positive social interaction)? Researchers will compare a group of pregnant women and their spouses who receive the seven-session educational program to a control group that receives only routine prenatal care, to see if the intervention reduces anxiety and enhances social support. Participants will:
• Attend seven weekly 60-minute face-to-face sessions together with their spouses, which include group discussions, lectures, and Q\&A
• Receive supplementary virtual messages (motivational and educational content) between sessions
• Complete questionnaires measuring COVID-19 anxiety and perceived social support at three time points: before the intervention, immediately after, and one month later

Conditions

Pregnancy; Anxiety; COVID-19; Social Support

Keywords

Prenatal anxiety; Pregnancy; Social support; Spouse-inclusive intervention

Outcome Measures

Primary Outcomes (2)

• COVID-19 Anxiety

  COVID-19-related anxiety measured by the Corona Disease Anxiety Scale (CDAS), an 18-item questionnaire assessing the psychological (items 1-9) and physical (items 10-18) symptoms of COVID-19-related anxiety. Responses are scored on a 4-point Likert scale ranging from 0 (never) to 3 (always), yielding a total score between 0 and 54, where higher scores indicate elevated anxiety levels. Reported Cronbach's alpha: 0.91.

  Baseline, immediately post-intervention (after seven weekly sessions), and one-month follow-up.

• COVID-19 Anxiety

  COVID-19-related anxiety measured by the Corona Disease Anxiety Scale (CDAS), an 18-item questionnaire assessing psychological (items 1-9) and physical (items 10-18) symptoms. Responses are scored on a 4-point Likert scale ranging from 0 (never) to 3 (always), yielding a total score between 0 and 54, with higher scores indicating elevated anxiety. Reported Cronbach's alpha: 0.91.

  Baseline, immediately post-intervention (after seven weekly sessions), and one-month follow-up.

Study Arms (2)

Control Group

NO INTERVENTION

Pregnant women who received standard routine prenatal care only, without any supplementary training regarding social support or COVID-19 anxiety reduction.

Intervention Group

EXPERIMENTAL

Pregnant women and their spouses who received the seven-session, spouse-inclusive, social-support-based educational intervention in addition to routine prenatal care. The intervention consisted of seven weekly 60-minute face-to-face sessions (limited to 11 couples per session) combining interactive discussions, formal lectures, and question-and-answer segments, reinforced by supplementary virtual messages containing motivational and educational content. Sessions covered an overview of the topic, participant introduction, program guidelines, session structure, and explanation of techniques. Outcomes were assessed at baseline, immediately post-intervention, and at a one-month follow-up.

Behavioral: Spouse-Inclusive Social Support Educational Intervention

Interventions

Spouse-Inclusive Social Support Educational Intervention BEHAVIORAL

A structured, seven-session educational program attended by both pregnant women and their spouses. Sessions were conducted face-to-face on a weekly basis, lasting 60 minutes each, and were facilitated by the lead researcher. Each session was limited to 11 couples to optimize group dynamics and interaction. The pedagogical approach integrated interactive discussions, formal lectures, and question-and-answer segments, which were further reinforced by supplementary virtual messages containing motivational and educational content.

Intervention Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age of up to 34 weeks
• Must be literate
• Possess a registered pregnancy record at the health center
• Own a smartphone
• No documented history of physical or mental health disorders for either the pregnant woman or her spouse
• Not involved in concurrent COVID-19 anxiety reduction programs

You may not qualify if:

• Experience of miscarriage or preterm birth during the study timeframe
• Withdrawal of consent
• Researcher-identified comprehension or learning difficulties
• Missing more than two intervention sessions

Sponsors & Collaborators

• Atefeh Dehnoalian: lead

Study Sites (1)

Mahdi Moshki

Gonābād, Razavi Khorasan Province, 05142632476, Iran

Location

MeSH Terms

Conditions

Anxiety Disorders; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Corresponding Author; Department of Nursing, Neyshabur University of Medical Sciences

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 2, 2026
• Study Start: December 10, 2021
• Primary Completion: December 10, 2024
• Study Completion: November 15, 2025
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Start Date: IPD and supporting information are stated to be available "upon reasonable request" to the corresponding author. End Date

Locations

IR (1)