The effect of spirituality-based relaxation techniques on the anxiety of nulliparous women
Design
Clinical trial, with intervention and control groups, with parallel, randomized groups
Settings and conduct
Venue: Health centers, holding 8 training sessions for the intervention group, before and after the intervention for both groups, the questionnaire will be completed.
Participants/Inclusion and exclusion criteria
Admission requirements: Eligible nulliparous women referring to Shiraz health centers-Native women more than 15 weeks pregnant's week-Iranian citizenship and diploma level higher-nulliparous women with moderate to mild anxiety level (based on Beck score anxiety questionnaire 25 and less) - Willingness to participate in the study and - Not having a high-risk pregnancy (multiple births, fetal problems, etc.) - No history of specific illness (physical or mental) or taking certain medications in the mother - Not participating in educational, relaxation or physiological classes in other centers - age 18-40 years. Exclusion criteria: Participants' dissatisfaction with continuing to participate in the study in any of the research stages - Occurrence of any disease during pregnancy that takes the participant out of the normal course of pregnancy. - Occurrence of any complications or stressful events during pregnancy - Non-compliance with the study protocol (Absence of more than one session in training classes)
Intervention groups
Intervention group: holding training workshops, control group: without intervention
Main outcome variables
Anxiety rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140622018187N11
Registration date:2020-08-11, 1399/05/21
Registration timing:registered_while_recruiting
Last update:2020-08-11, 1399/05/21
Update count:0
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
Sedighe Forouhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 987136474257
Email address
foruharis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of relaxation techniques with spiritual interventions on the level of anxiety in nulliparous women
Public title
The effect of relaxation techniques with spiritual interventions on the level of anxiety in nulliparous women referred to health centers affiliated to Shiraz University of Medical Sciences 98-99
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Eligible primiparous women referring to Shiraz health centers-Primiparous women with more than 15 weeks of gestation-Iranian citizenship and diploma level higher-Primary primiparous women with moderate to mild anxiety level (according to Beck Anxiety Questionnaire score 25 and less It) - willingness to participate in the study and - not having a high-risk pregnancy (multiple births, fetal problems, etc.) - no history of a specific disease (physical or mental) or taking a specific drug in the mother - no participation In educational, relaxation or physiological classes in other centers - age 18-40 years
Exclusion criteria:
Dissatisfaction of participants to continue participating in the study in any of the research stages - Occurrence of any disease during pregnancy that takes the participant out of the normal course of pregnancy. - Occurrence of any complications or stressful events during pregnancy - Non-compliance with the study protocol From a session in training classes)
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The population of eligible women is randomly assigned to two groups using a random permutation block design. The groups are placed and if the numbers 5 to 9 are observed, two people are placed in two groups as BA permutations and we repeat this until we have 48 people in each group. Thus, the samples are divided into two groups A (intervention group) And group B (control group) are divided. Women are also informed that they will be accidentally placed in one of the groups.
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 Shiraz University of Medical Sciences
Street address
Fatemeh School of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2018-10-12, 1397/07/20
Ethics committee reference number
IR.SUMS.REC.1398.1003
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety
Primary outcomes
1
Description
Anxiety in pregnant women
Timepoint
Before and after the workshop
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the pre-intervention stage, the researcher will explain the stages and manner of the research and its objectives, and then provide the participants with an ethical consent form, then the participants of the intervention group will be asked to participate in the prepared sessions. . The control group will also participate in routine classes that are performed in health centers (in the form of CDs provided by childbirth preparation classes). Training in the intervention group is spiritual relaxation based on virtual training and using Social networks are held in 8 sessions of less than 60 minutes and groups of 20 to 30 people. In addition, in the intervention group, a booklet of homework is provided to the participants to spend 20-30 minutes daily to do their daily homework and exercises.
Category
Lifestyle
2
Description
Control group: In the control group, relaxation is done with the usual method in the form of training CDs of childbirth preparation classes and individually or in groups, which is done according to the routine of the centers.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers (public and private) affiliated to the University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Street address
Shiraz University of Medical Science, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4257
Email
forouharism@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Unes Ghasemi
Street address
Technology and Research Office, Research Deputy , Shiraz University of Medical Science, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
73148-14336
Phone
+98 71 3230 5410
Email
president@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Ph.D , Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4257
Email
forouharism@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Foruhari
Position
Ph.D , Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4257
Email
forouharism@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Ph.D , Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4257
Email
forouharism@yahoo.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