The study was designed to determine the effect of Benson relaxation and telephone counseling on pregnancy's worries and stress
Design
This trial has 2 intervention groups (Benson and phone counseling) and 1 control group, each group includes 27 people, with parallel groups, without blinding, randomized, on 81 patients (with Considering the fall, 90 people). For randomization, a table of random numbers is used
Settings and conduct
90 pregnant women referring to Alborz health centers with the characteristics of the research unit are selected and then randomly placed in one of the 3 groups receiving telephone counseling, Benson group and control group. In the relaxation group, after one training session, the mother is asked to do relaxation for 15-20 minutes twice a day for 4 weeks. In the counseling group, counseling is given through telephone counseling (for 4 weeks). Maternal worries and stress in all three groups before and after the intervention with the pregnancy's worries and stress questionnaire (PWSQ) will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: mother age 18-35 - At least fifth grade literacy- First pregnancy-Gestational age in the third trimester ( 28-34 w) - Single pregnancy - Pregnant mothers have access to the Internet- Low risk pregnancy
Exclusion criteria: obvious fetal abnormalities _ stressful events (accident, etc.) during the last six months_ mental illness_ addiction to drugs_ using alcohol_ history of infertility and speech and hearing disorders
Intervention groups
1 Benson group, the mother is asked to do relaxation for 15 to 20 minutes twice a day for 4 weeks
2 - A group through counseling telephone (in such a way that during 4 sessions, one 45-60 minute session per week, related topics are held via Skype or Whats-app)
3- The control group receives routine pregnancy care
Main outcome variables
Worries and stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210625051699N1
Registration date:2021-08-01, 1400/05/10
Registration timing:registered_while_recruiting
Last update:2021-08-01, 1400/05/10
Update count:0
Registration date
2021-08-01, 1400/05/10
Registrant information
Name
Sahar Hasanpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6551 2606
Email address
saharhasanpoor@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Benson´s relaxation technique and phone consultation on pregnancy's worries and stress
Public title
The effects of relaxation and consultation on pregnancy's stress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mother age 18-35
At least fifth grade literacy
First pregnancy
Gestational age in the third trimester ( 28-34 ) weeks
Single pregnancy
Low risk pregnancy
Having access to the Internet
Exclusion criteria:
Absence of obvious fetal abnormalities
Absence of stressful events (accident, etc.) during the last six months
Absence of mental illness
Not using or addiction to drugs
Not using psychedelics and alcohol
Not having history of infertility and speech and hearing disorders
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way using a table of random numbers. In this way, the members of the research will be numbered from 1 to 90 and we will randomly put the number of people from 1 to 90 in the table without any special order. Then a row and column from the table are randomly selected, the intersection point of the row and column is the starting point of sampling. From this point, and chosen by the researcher, we determine a direction (for example, up, down, right or left) to read the table numbers, then we assume specific numbers for each of the study groups. For example: the numbers 1-30 enter the first intervention group (Benson) and if it is 31-60 the second intervention group (telephone counseling), the numbers 61-90 enter the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shaid Arabi Ave., Yaman Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-06-29, 1400/04/08
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.073
Health conditions studied
1
Description of health condition studied
Worries and stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
Primary outcomes
1
Description
Pregnancy's worries and stress
Timepoint
Measurement of pregnancy's worries and stress score is done before the intervention and immediately after the intervention.
Method of measurement
Pregnancy's Worries and Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: After holding a Benson relaxation training session, mothers are taught using simple and understandable sentences, and in this way, the mother is in the best position in which she feels calm. He sits or lies down, closes her eyes, in which case she chooses a word that always reminds her of peace (such as the word of the god of rain, flowers, etc.) and begins to take deep, regular breaths. It inhales through the nose and exhales through the mouth, repeating the word in the mind with each exhalation. In this position, release the muscles from the toes and continue this work to the upper muscles of the body until all the muscles are fully expanded and maintain this position for 10 to 20 minutes. We then advise the mother to refrain from changing posture immediately after the technique. For more effect, we recommend relaxing music while performing the technique. The intervention group performs exercises for 4 weeks, twice a day and each time for 15-20 minutes at home.
Category
Behavior
2
Description
Intervention group 2:A group receives counseling through counseling with mobile software and remotely to reduce worries and stress (in such a way that during 4 weekly sessions, a 45-60 minute session Related content is held via Skype or Whats App) and the content of the counseling is based on the Gamble study counseling model and the strategy of this counseling includes: (Therapeutic communication between midwife and mother, in the first week, mother support and Expressing emotions in the second week, providing information in the third week, reinforcing positive thoughts and discovering appropriate solutions to reduce stress and worry in the fourth week), which is taught to mothers virtually and remotely.
Category
Behavior
3
Description
Control group: The control group receives routine pregnancy care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz Health Centers
Full name of responsible person
Sahar Hasanpoor
Street address
No.31, Azar Ave.,Motahari Blvd., Karaj Town
City
karaj
Province
Alborz
Postal code
3143663471
Phone
+98 21 6551 2606
Email
saharhasanpoor77@gmail.co
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Yaman Ave., Blvd., Chamran highway ., TehranTown
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Hasanpoor
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.31, Azar Ave.,Motahari Blvd., Karaj Town
City
Karaj
Province
Alborz
Postal code
3143663471
Phone
+98 21 6551 2606
Email
saharhasanpoor77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahnaz Tork Zahrani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
zahranishahnaz@yahoo.co
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Hasanpoor
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shaid Arabi Ave., Yaman Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 6551 2606
Email
saharhasanpoor77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available