The effect of progressive muscle relaxation on nausea and vomiting in pregnant women
Design
This study is a randomized clinical trial with two groups (intervention and control), pre and post-test design, and not-blinded.
Settings and conduct
Relaxation training is taught to the intervention group during two sessions. In the control group, education is not given by the researcher. The Rhodes questionnaire will complet before and after the intervention by the research units.
Participants/Inclusion and exclusion criteria
Gestational age below 12 weeks based on the first day of the last menstruation or ultrasound;
Single pregnancy;
Reading and writing literacy;
Wanted pregnancy;
Ability to use Compact Disc Muscle Relaxation;
Lack of major physical and mental illness;
Earning a score of less than 10, 14, 17 in response to the DOS-21 questionnaire in depression, anxiety and stress respectively;
No use of nausea and vomiting and anti-anxiety drugs;
No use of fertility methods for pregnancy;
No Smoking, Drug, and Alcohol use;
No significant stressful incidents during the past six months;
Not using relaxation during pregnancy;
Gain a score of 16-3 Rhodes instruments;
Unwillingness to participate in the study.
Intervention groups
In the intervention group, Jakobson's progressive muscle relaxation by the researcher is taught in two 60-minute sessions. The intervention group takes relaxation at home for 4 weeks, twice a day (in the morning and evening for 20 minutes. This intervention is not given to control group but only receives routine care from health centers.
Main outcome variables
nausea and vomiting in pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180802040675N1
Registration date:2018-08-16, 1397/05/25
Registration timing:registered_while_recruiting
Last update:2018-08-16, 1397/05/25
Update count:0
Registration date
2018-08-16, 1397/05/25
Registrant information
Name
Zahra SHourgashti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4335 0519
Email address
shourgashtiz931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-16, 1397/05/25
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive muscle relaxation on nausea and vomiting in pregnant women
Public title
The effect of Jacobson's progressive muscle relaxation on nausea and vomiting in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Gestational age below 12 weeks based on the first day of the last menstruation or ultrasound 2- Single pregnancy 3- Reading and writing literacy 4- Pregnancy asked 5- Ability to use Compact Disc Muscle Relaxation 6- Lack of major physical and mental illness 7- Earning a score of less than 10, 14, 17 in response to the DOS-21 questionnaire in depression, anxiety and stress, respectively 8- Non-use of nausea and vomiting and anti-anxiety drugs 9- Non-use of fertility methods for pregnancy 10- No Smoking, Drug, and Alcohol 11- Failure to have significant stressful incidents during the past six months 12- Not using relaxation during pregnancy 13- The Rhodes Index score of 16-3
Exclusion criteria:
Unwilling to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The Intended health center is picked out with a draw in such a way that names of five health centers of Mashhad (health center number one, two, three, five, and samen) are written on five papers and is put in a container and a person who is not one of the team members takes a paper out of container which is the name of selected health center.
Among the health centers covered by selected center, two health centers are selected randomly based on the most number of referred pregnant women, a center for intervention group and a center for control group .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-07-28, 1397/05/06
Ethics committee reference number
IR.MUMS.REC.1397.114
Health conditions studied
1
Description of health condition studied
Nausea and vomiting in pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea and vomiting in pregnant women
Timepoint
Before intervention, two weeks after the intervention, four weeks after the intervention
Method of measurement
"Rhodes" Nausea and Vomiting Standard Test Questionnaire
Secondary outcomes
1
Description
Anxiety, depression and stress in pregnant women
Timepoint
Before the intervention, two weeks after the intervention, four weeks after the intervention
Method of measurement
Depression, Anxiety and Stress Questionnaire DASS-21
Intervention groups
1
Description
Intervention group: CD of progressive muscle relaxation is given to case group. After training, 2 times daily (morning & evening) for one month, case group perform relaxation and then are assessed in next two weeks & 1 month later with using of Rhodes questionnaire and compare with control group.
Category
Lifestyle
2
Description
Control group: CD of progresive mascle relaxation isn't gave to control group. nausea and vomiting is assessed in first visit and in next two weeks & 1 month later with using of Rhodes questionnaire and compared with case group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad No 1 Health Center
Full name of responsible person
Dr Naser Amini
Street address
shahrbani Town, Vakilabad Blvd,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۸۹۹۱۹۱
Phone
+98 51 3501 8011
Email
m1hcenter@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Phone
+98 51 3841 1538
Email
vcresearc@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/index.php
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Shourgashti
Position
Master of Science Student in Public Health
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 4335 0519
Email
shourgashtiz931@mums.ac.ir
Web page address
http://nurse.mums.ac.ir/index.php
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Emami moghadam
Position
Master of Science in Nursing
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
+98 51 3852 8512
Phone
+98 51 3607 8926
Email
Emamiz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra SHourgashti
Position
Master of Science Student in Public Health
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
+98 51 3852 8512
Phone
+98 51 4335 0519
Email
shourgashtiz931@mums.ac.ir
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