Protocol summary
-
Study aim
-
Determining the effect of Benson relaxation method on anxiety and hemodynamic parameters in women before cesarean section
-
Design
-
It is a two-group clinical trial in which the study population consists of all mothers waiting for cesarean section.
-
Settings and conduct
-
Receiving face-to-face relaxation training by the researcher to hospitalized mothers waiting for cesarean section and listening to the relaxation audio file at least 3 times before cesarean section
Bahar and Khatam Al-Anbia Educational, Research and Treatment Centers
-
Participants/Inclusion and exclusion criteria
-
All mothers waiting for cesarean section who are at least 18 and at most 36 years old, have no hearing loss, muscle paralysis, thyroid disorder, known mental illness and previous history of cesarean section and similar courses of muscle relaxation, sedative use in the last 24 hours and ability to understand Persian language and obtaining an anxiety score of 7 and above from the hospital anxiety tool.
-
Intervention groups
-
Intervention group of 31 people (routine care with relaxation)
-
Main outcome variables
-
Anxiety; blood pressure; Pulse rate; Number of breaths
General information
-
Reason for update
-
The change in the sample size is due to the change in the conditions of inclusion in the study of this edition.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200718048128N1
Registration date:
2020-08-05, 1399/05/15
Registration timing:
retrospective
Last update:
2024-09-07, 1403/06/17
Update count:
1
-
Registration date
-
2020-08-05, 1399/05/15
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-01-02, 1397/10/12
-
Expected recruitment end date
-
2019-07-03, 1398/04/12
-
Actual recruitment start date
-
2019-01-02, 1397/10/12
-
Actual recruitment end date
-
2020-01-02, 1398/10/12
-
Trial completion date
-
2020-01-02, 1398/10/12
-
Scientific title
-
The effect of relaxation technique on anxiety and hemodynamic parameters in women before cesarean section
-
Public title
-
The effect of Benson relaxation technique on anxiety and hemodynamic parameters in women before cesarean section
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
All mothers are waiting for a cesarean section
Exclusion criteria:
History of previous cesarean section
-
Age
-
From 18 years old to 36 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
62
Actual sample size reached:
62
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The samples of this study included 62 eligible mothers with the consent of participating in the study, based on the allocation sequence produced by block method in volume 4, were randomly assigned to the study and control groups.For secrecy of the allocation sequence, since the two sample centers were collected simultaneously, the central secrecy method was used.Thus, the allocation sequence was in the hands of an individual outside the research team, and the relevant expert in each center, after registering the participants for the allocation of each individual, contacted the individual and assigned the participant to the intervention or control group.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2016-12-21, 1395/10/01
-
Ethics committee reference number
-
IR.SHMU.REC.1395.101
Health conditions studied
1
-
Description of health condition studied
-
cesarean section
-
ICD-10 code
-
P03.4
-
ICD-10 code description
-
Newborn (suspected to be) affected by Cesarean delivery
Primary outcomes
1
-
Description
-
Anxiety
-
Timepoint
-
The experimental group listened to the audio file of the relaxation training for 6 minutes and at least 3 times before the operation, 3-5 hours before cesarean section (the beginning of relaxation training is from the beginning of the morning, which does not interfere with the patient's sleep). He will practice Benson according to the instructions on the relaxation bar.
-
Method of measurement
-
Hospital Anxiety and Depression Scale (Anxiety Questions Only) and Hemodynamic Information Form
Secondary outcomes
1
-
Description
-
Hemodynamic indicators
-
Timepoint
-
The experimental group listened to the audio file of the relaxation training for 6 minutes and at least 3 times before the operation, 3-5 hours before cesarean section (the beginning of relaxation training is from the beginning of the morning, which does not interfere with the patient's sleep). He will practice Benson according to the instructions on the relaxation bar.
-
Method of measurement
-
Hemodynamic information form
Intervention groups
1
-
Description
-
Intervention group: All mothers waiting for cesarean section admitted to the educational-medical center (routine care with relaxation). The intervention group, after receiving face-to-face training of the relaxation method by the researcher and gaining the researcher's confidence in learning this method, listened to an audio file of relaxation training 3-5 hours before cesarean section and at least 3 times before cesarean section according to the instructions. Spread on a Benson muscle relaxation tape will practice (start relaxation training early in the morning that does not interfere with the patient's sleep)
-
Category
-
Behavior
2
-
Description
-
Control group: The control group also receives routine ward care.
-
Category
-
N/A
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Shahroud 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
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
-
It has not been in the methodology.
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available