Investigating the effectiveness of Jacobsen relaxation training on the level of anxiety of pregnant women hospitalized in the complicated pregnancy department
Determining the effectiveness of Jacobsen relaxation training on the level of anxiety of pregnant women admitted to the complicated pregnancy ward
Design
The clinical trial has a control group with parallel groups. The participants are randomly allocated to two intervention groups and control groups through the online software (www.Random.org/sequences). The sample size is 44 people. There is no trial phase.
Settings and conduct
Complicated pregnancy department of Shahid Sadoughi Hospital in Yazd is the place of study. Jacobson relaxation training is conducted in 4 sessions of 60 minutes, twice a week, in person, and an educational pamphlet is provided to the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Having informed consent and willingness to participate in the study
• Diagnosis of complicated pregnancy and prediction of at least two weeks hospitalization in the complicated pregnancy department of Shahid Sadoughi Hospital by a gynecologist.
• Women of reproductive age
• Pregnancy age 14-34 weeks (based on the exact date of the first day of the last menstrual period or ultrasound under 20 weeks)
• Iranian nationality
• Ability to understand and speak Persian language and cooperate in exercises
Exclusion criteria:
• Participating in mental health-related intervention studies at the same time
• Existence of various types of mental disorders
•Existence of stressful events during the last 6 months such as immigration, death of relatives, divorce and financial problems
• Smoking, drugs and alcohol
Intervention groups
For the intervention group, the Jacobson method of relaxation technique training is conducted in 4 sessions of 60 minutes twice a week and in person. For the control group, an educational pamphlet is provided on the importance of stress control during pregnancy.
Main outcome variables
The level of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230725058915N1
Registration date:2023-09-24, 1402/07/02
Registration timing:prospective
Last update:2023-09-24, 1402/07/02
Update count:0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Fateme Jamashi
Name of organization / entity
Shahid sadoghi
Country
Iran (Islamic Republic of)
Phone
+98 35 3828 2718
Email address
fatemejamashi0072@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of Jacobsen relaxation training on the level of anxiety of pregnant women hospitalized in the complicated pregnancy department
Public title
Effectiveness of Jacobsen relaxation training on the level of anxiety of pregnant women hospitalized in the complicated pregnancy department
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of complicated pregnancy and prediction of at least two weeks hospitalization in the complicated pregnancy department of Shahid Sadoughi Hospital by a gynecologist.
Willingness to participate in the study
Having informed consent to participate in the study
Women of reproductive age
Gestational age 14-34 weeks
Iranian nationality
Ability to understand and speak Persian and cooperate in doing exercises
Exclusion criteria:
Participating in concurrent mental health-related intervention studies
Existence of various types of mental disorders such as psychosis, schizophrenia, anxiety which is under medical treatment based on the information of the medical record or the patient's own statements.
Existence of stressful events during the past 6 months
Smoking, drugs and alcohol
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Using random number sequence and online software (www.Random.org/sequences), research units are assigned to two groups of 30 people: motivational interview and pelvic floor exercises 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
Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar square, the central building of Shahid Sadoughi University of Medical Sciences, Yazd Town
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.SSU.REC.1402.034
Health conditions studied
1
Description of health condition studied
Anxiety during pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of anxiety
Timepoint
First and immediately and two weeks after the intervention
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Jacobson relaxation training is conducted in 4 sessions of 60 minutes and twice a week
Category
Prevention
2
Description
Control group: An educational pamphlet is provided for the control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Complicated Pregnancy, Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Fatemeh Jamashi
Street address
Shahid Qandi Blvd, Ibn Sina Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
89158 87857
Phone
+98 35 3822 4000
Fax
+98 35 3822 4000
Email
info@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. seyed mehdi hashemi bajgani
Street address
Bahonar square, central building of Shahid Sadougi University of Medical Sciences, Yazd Town
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3374 0171
Fax
+98 35 3725 4750
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Zaremobini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bu Ali St,Timsar falahi St, Yazd
City
Yazd
Province
Yazd
Postal code
0
Phone
+98 35 3824 1751
Email
fatemehzaremobini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh ZareMobini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bu Ali St,Timsar falahi St, Yazd
City
Yazd
Province
Yazd
Postal code
0
Phone
+98 35 3824 1751
Email
fatemehzaremobini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh ZareMobini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bu Ali St,Timsar falahi St, Yazd
City
Yazd
Province
Yazd
Postal code
0
Phone
+98 35 3824 1751
Email
fatemehzaremobini@yahoo.com
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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available