PregnancyPublic healthNCT07856576
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
A study testing Spouse-Inclusive Social Support Educational Intervention in people with Pregnancy and Anxiety, run by Atefeh Dehnoalian at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- What is being tested?
- Spouse-Inclusive Social Support Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIran
- Study dates
- 10 Dec 2021to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)?
Read more
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
- Being tested
- Spouse-Inclusive Social Support Educational Intervention
- Keywords
- Prenatal anxiety, Pregnancy, Social support, Spouse-inclusive intervention
- Medical subject headings
- Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spouse-Inclusive Social Support Educational InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Spouse-Inclusive Social Support Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, immediately post-intervention (after seven weekly sessions), and one-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start10 Dec 2021
- Primary completion10 Dec 2024
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atefeh Dehnoalian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Atefeh Dehnoalian, Gonabad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856576
- Sponsor's protocol ID
- IR.GMU.REC.1400.071
- Acronym
- Public health
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07856576
- Acronym / sponsor ID
- Public health / IR.GMU.REC.1400.071
- Conditions
- Pregnancy, Anxiety, COVID-19, Social Support
- Keywords
- Prenatal anxiety, Pregnancy, Social support, Spouse-inclusive intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Atefeh DehnoalianUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Spouse-Inclusive Social Support Educational InterventionPregnant 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spouse-Inclusive Social Support Educational InterventionA 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. | Behavioural | Intervention Group |
Primary outcome
COVID-19 Anxiety
Time frame: Baseline, immediately post-intervention (after seven weekly sessions), and one-month follow-up.
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.
COVID-19 Anxiety
Time frame: Baseline, immediately post-intervention (after seven weekly sessions), and one-month follow-up.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spouse-Inclusive Social Support Educational Intervention in people with Pregnancy and Anxiety, run by Atefeh Dehnoalian at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Anxiety (time frame: Baseline, immediately post-intervention (after seven weekly sessions), and one-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.