The effect of progressive muscle relaxation on the anxiety of primigravida mothers with premature children admitted to the neonatal intensive care unit
Determining the effect of progressive muscle relaxation on the anxiety of primigravida mothers with premature children admitted to the neonatal intensive care unit.
Design
This study is a two-group clinical trial (intervention-control) pre-test and post-test. The sampling method in this study is accessible. Then, with the random block method, 10 blocks with 6 modes will be used. The letter A represents the participant of the intervention group and the letter B represents the participant of the control group. 66 patients in the two intervention and control groups will be randomly selected from the blocks based on the sequence of entry and according to the block pattern, and will be divided into two intervention and control groups.
Settings and conduct
After sampling at Amir Kabir Hospital in Arak, the demographic information form and the Spielberger Anxiety Questionnaire will be completed before the intervention in both groups. The Spielberger anxiety questionnaire will be completed by both groups after the end of the intervention. Then the data will be entered into the statistical software and the results will be analyzed by statistical methods.
Participants/Inclusion and exclusion criteria
A primigravida mother with a premature child admitted to the neonatal intensive care unit;According to the Spielberger anxiety questionnaire, the mother should have moderate to severe anxiety.
Intervention groups
The people in the intervention group will be asked to perform the Jacobson relaxation technique 2 times a day for 3 consecutive days and a total of 6 sessions, each session lasting 20 to 30 minutes.
The control group will not receive the intervention during this period.
Main outcome variables
Anxiety of primigravida mothers with premature children hospitalized in the neonatal intensive care unit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240723062521N1
Registration date:2024-08-12, 1403/05/22
Registration timing:prospective
Last update:2024-08-12, 1403/05/22
Update count:0
Registration date
2024-08-12, 1403/05/22
Registrant information
Name
Negar Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3425 8062
Email address
negarkarami88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive muscle relaxation on the anxiety of primigravida mothers with premature children admitted to the neonatal intensive care unit
Public title
The effect of progressive muscle relaxation on the anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mother's willingness to participate in the study
A primigravida mother with a premature child is hospitalized in the neonatal intensive care unit
According to the Spielberger anxiety questionnaire, the mother should have moderate to severe anxiety (score 40 or more).
Exclusion criteria:
Presence of mental illness known through questioning the mother
Taking anti-anxiety drugs, opioids or strong painkillers
The presence of inhibition of contraction and frequent muscle expansions
Having twins or multiple babies
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The research units will be selected as available and will be randomly assigned in two intervention and control groups using the alternative block randomization technique. 10 blocks with 6 modes will be used. The letter A will represent the participant of the intervention group and the letter B will represent the participant of the control group. The samples in the intervention and control groups will be randomly selected from the blocks based on the sequence of entry and according to the block pattern and will be assigned to the intervention and control 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 Arak University of Medical Sciences
Street address
No. 13, Block A,Treatment and Medical Education,Central Headquarters of the Ministry of Health, between South Flamek and Zarafshan, Simai Iran St., Quds town (west), Tehran
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2024-06-23, 1403/04/03
Ethics committee reference number
IR.ARAKMU.REC.1403.143
Health conditions studied
1
Description of health condition studied
Anxiety of primigravida mothers with premature children admitted to the neonatal intensive care unit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety caused by the fear of illness and hospitalization in patients and their caregivers.
Timepoint
Before the intervention and three days after the start of relaxation sessions
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In the intervention group, in addition to receiving the usual hospital procedures, they will begin to implement relaxation techniques in a private and quiet place. The technique will be performed 2 times a day for 3 consecutive days and a total of 6 sessions, each session lasting 20 to 30 minutes. Thus, in the first session, we will teach mothers to first contract the muscles of the soles of their feet to the muscles of the face by counting to the number of 5 and then expand them by counting to the number of 10 until they feel that their whole body is relaxed and relaxed and at the same time Breathe deeply during relaxation. To better understand how to perform the technique in the next sessions, the intended intervention will be provided to the study participants in the form of a video file that can be used on mobile phones.
Category
Rehabilitation
2
Description
Control group:In the control group, these measures are not performed and they will only receive the usual hospital measures without any reductions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir
Full name of responsible person
Negar Karami
Street address
Nurse Square, Shahid Shiroudi St., Arak
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
amirkabir-hospitai@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Negar Karami
Street address
Alam El Hadi St, Shahid Shiroudi St., Arak
City
Arak
Province
Markazi
Postal code
646
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Negar Karami
Position
Bachelor student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.3,Arghavan alley,Pooriavally St,
City
Arak
Province
Markazi
Postal code
3816584145
Phone
+98 86 3425 8062
Fax
Email
negarkarami88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Behzad Hamedani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Blue ball, nursing school, University complex of the great prophet, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
Hamedanibehzad166@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Negar Karami
Position
Bachelor student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.3,Arghavan alley,Pooriavally St,
City
Arak
Province
Markazi
Postal code
3816584145
Phone
+98 86 3425 8062
Fax
Email
negarkarami88@gmail.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 additional information 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