Determining the effect of telephone counseling on COVID-19-related health anxiety in pregnant women referred to Saveh health centers
Design
This study was a randomized controlled clinical trial. Simple random sampling was performed among pregnant women referring to Saveh Health Center (5 centers) who provided midwifery services. Then they were divided into intervention (A) and control (B) by block randomization method.
Settings and conduct
After sampling and random allocation of samples, they were asked to complete a demographic and health anxiety questionnaire. Then the intervention group was given telephone counseling and the control group was not given counseling. After one month, the test post was taken by telephone from both groups. The counseling session consisted of two 30-minute telephone calls. Each sample in the intervention group received telephone counseling at least twice, one to two weeks apart. The consultation was conducted by a senior midwifery consultant who has a history of counseling.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No family conflicts or mental and psychological problems, no history of any psychological disease, no history of using antidepressants and psychiatric medications, and access to the telephone. Exclusion criteria: unwillingness to continue participation in the study and the happening of any crisis and stressful situation for the mother during the study
Intervention groups
Pregnant Mothers
Main outcome variables
Health Anxiety Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220531055038N1
Registration date:2022-06-13, 1401/03/23
Registration timing:retrospective
Last update:2022-06-13, 1401/03/23
Update count:0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
Sahar Yazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4224 4557
Email address
saharyazdi@savehums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-09, 1401/01/20
Actual recruitment start date
2022-03-01, 1400/12/10
Actual recruitment end date
2022-04-19, 1401/01/30
Trial completion date
2022-04-30, 1401/02/10
Scientific title
The Effect of Telephone Counseling on Covid-19-related Health Anxiety in Pregnant Women: A randomized controlled trial
Public title
The effect of counseling on coronary anxiety in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women who refer to selected health centers
Willing to participate in the study
Exclusion criteria:
Inclusion criteria were willingness to participate in the study, no family conflicts or mental and psychological problems
no history of any psychological disease
no history of using antidepressants and psychiatric medications, and access to the telephone
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
85
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
This study was performed on 85 pregnant women referred to Saveh health centers. After obtaining the necessary approvals and attracting the participants, the objectives of the research were explained to them and the mothers were asked to sign their written consent. Random sampling was performed by participants from all five health centers in Saveh that provided midwifery services. First, a list of pregnant mothers was prepared and then, using a random number table, participants from each center (proportional to the number of mothers covered by them) were selected from among the eligible inclusion criteria. Then they were divided into intervention (A) and control (B) by block randomization method. First, 17 blocks of 5 are listed as follows: AAAAB, AAABB, AABBB, ABBBB,… Then these blocks were arranged using a table of random numbers and individuals were assigned to two groups according to A and B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the study (counseling and training), which was not possible for the researcher and participant to be blinded, the analyzer and evaluator were given codes A and B. The intervention group received code A and control code B and had no information about the type of study and groups.
Placebo
Not used
Assignment
Other
Other design features
The consultation session consisted of two 30-minute phone conversations consisting of three parts. In part one, explanations were provided about coronavirus epidemiology in the region, definition and symptoms of the disease, how to care for pregnant women and protect them during the pandemic, how to schedule telephone counseling sessions and visits with gynecologists (to avoid unnecessary visits), providing the necessary information about the maternal-fetal transmission of the virus, answering to ambiguities around the choose of the right person who would follow the instructions during delivery, how to choose the safest place for delivery, how to breastfeed during the pandemic time, and how to care for the baby in the hospital and at home during the coronavirus era. Part two was dedicated to teaching relaxation techniques, which was accompanied by sending a file containing training about these techniques for ensuring better knowledge and practice. Finally, the 5-minute part three was considered for answering questions, following up for needs, and obviating the problems of the participant.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Saveh University of Medical Sciences
Street address
Saveh university ,Behest Ave,Fahmideh Blvd
City
Saveh
Province
Markazi
Postal code
3919953649
Approval date
2020-12-23, 1399/10/03
Ethics committee reference number
این طرح دارای کد اخلاق IR.SAVEHUMS.REC.1399.027
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Primary outcome: health anxiety rate; In this study, the effect of telephone counseling on COVID-19-related health anxiety in pregnant women was investigated. The level of health anxiety was assessed using the Salkovskis and Warwick's health anxiety questionnaire by telephone before and after the intervention.
Timepoint
1 Month
Method of measurement
demographic checklist and the health anxiety Salkowski & Warwick questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants were initially requested to complete a demographic checklist and the health anxiety questionnaire. The consultation session consisted of two 30-minute phone conversations consisting of three parts. In part one, explanations were provided about coronavirus epidemiology in the region, definition and symptoms of the disease, how to care for pregnant women and protect them during the pandemic, how to schedule telephone counseling sessions and visits with gynecologists (to avoid unnecessary visits), providing the necessary information about the maternal-fetal transmission of the virus, answering to ambiguities around the choose of the right person who would follow the instructions during delivery, how to choose the safest place for delivery, how to breastfeed during the pandemic time, and how to care for the baby in the hospital and at home during the coronavirus era. Part two was dedicated to teaching relaxation techniques, which was accompanied by sending a file containing training about these techniques for ensuring better knowledge and practice. Finally, the 5-minute part three was considered for answering questions, following up for needs, and obviating the problems of the participant. ONE - Two week after intervention, the health anxiety questionnaire was completed again via making phone calls to the participants.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
health Care Center
Full name of responsible person
Sahar Yazdi
Street address
Taleghani Ave
City
Saveh
Province
Markazi
Postal code
3918698786
Phone
+98 86 4222 2080
Fax
+98 86 4222 6653
Email
saharyazdi.1379@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Dr Morteza Hemat
Street address
Beheshti Ave, Fahmideh Blvd
City
Saveh
Province
Markazi
Postal code
3919953649
Phone
+98 86 4225 0203
Email
saharyazdi.1379@gmail.com
Grant name
1399-027
Grant code / Reference number
1399-02.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Saveh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Sahar Yazdi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Beheshti Ave,Fahmideh Blvd
City
saveh
Province
Markazi
Postal code
3919953649
Phone
+98 86 4225 0203
Email
saharyazdi.1379@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Sahara yazdi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Beheshti Blvd, Fahmideh Ave
City
saveh
Province
Markazi
Postal code
3919953649
Phone
+98 86 4225 0203
Email
saharyazdi.1379@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sahar Yazdi
Position
Consultant and Teacher
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.8,Nadiri Ave.,faz 2., Fajr Town
City
Saveh
Province
Markazi
Postal code
3919953649
Phone
+98 86 4224 4557
Fax
Email
saharyazdi@savehums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The e-mail of the responsible author will be included in the article and the subscribers will be provided with shareable items at the request of the audience.
When the data will become available and for how long
There is no time limit.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The results of the project can be obtained and extracted only by mentioning the source.
From where data/document is obtainable
Author
What processes are involved for a request to access data/document