Comparison of the effectiveness of muscle relaxation training in both face-to-face and distance methods on stress, anxiety and sleep quality in pregnant women with hypothyroidism
Determining and comparing the effectiveness of muscle relaxation training in both face-to-face and distance methods on stress, anxiety and sleep quality in pregnant women with hypothyroidism
Design
A clinical trial with a control group, random sampling, phase 1 on 66 pregnant women with hypothyroidism, a table of numbers was used for randomization.
Settings and conduct
Muscle relaxation training in both face-to-face and distance
Place of study: In coordination with the management of the Free Technical and Vocational Training Center, the House of Skills, which is a specialized center for massage and temperament training; This place was intended for face-to-face training of the samples.
Participants/Inclusion and exclusion criteria
Entry requirements
Pregnant women with hypothyroidism,
Do not use other pharmacological and non-pharmacological methods of anti-anxiety, anti-stress
No entry conditions
Absence from more than one session in class
Non-pregnancy with assisted reproductive techniques
Creating high-risk pregnancy conditions
Dissatisfaction or unwillingness to continue reading
Intervention groups
Face-to-face training group, Distance education group
Main outcome variables
Stress level of individuals based on perceived stress questionnaire
Anxiety level based on Spielberger overt and covert anxiety questionnaire
People's score based on the Petersburg Sleep Quality Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220427054683N1
Registration date:2022-05-07, 1401/02/17
Registration timing:prospective
Last update:2022-05-07, 1401/02/17
Update count:0
Registration date
2022-05-07, 1401/02/17
Registrant information
Name
afsaneh emanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4264 3000
Email address
in.sodako@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2022-05-31, 1401/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of muscle relaxation training in both face-to-face and distance methods on stress, anxiety and sleep quality in pregnant women with hypothyroidism
Public title
Comparison of the effectiveness of muscle relaxation training in both face-to-face and distance methods on stress, anxiety and sleep quality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having hypothyroidism
Not suffering from mental disorders and diseases
Non-use of other pharmacological and non-pharmacological methods of anti-anxiety, anti-stress and the absence of effective crises in the last 6 months (loss of parents, divorce)
For face-to-face training group: Ability to attend classes in terms of physical and family conditions
For distance education group: having a smart phone and the ability to work with virtual networks
Exclusion criteria:
Absence of more than one session in class
Non-pregnancy by assisted reproduction methods
No history of Anomalous baby birth
Having high-risk pregnancy conditions such as diabetes or miscarriage while studying
Reluctance to continue cooperation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
The names were arranged alphabetically and each person was assigned a number and were divided into two groups, one in person and one in absentia.
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 Najafabad Azad University
Street address
University Blvd, Najafabad.
City
Najafabad
Province
Isfehan
Postal code
581413131
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1399.124
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress level of individuals based on perceived stress questionnaire
Timepoint
Before intervention and after intervention
Method of measurement
Perceived stress questionnaire (pass14)
2
Description
Anxiety level based on Spielberger overt and covert anxiety questionnaire
Timepoint
Before intervention and after intervention
Method of measurement
Spielberger overt and covert anxiety questionnaire
3
Description
People score on the Petersburg Sleep Quality Questionnaire
Timepoint
Before intervention and after intervention
Method of measurement
Petersburg Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Face-to-face training group: Pregnant women with hypothyroidism were asked to visit twice a week and perform movements in person and in the presence of a researcher. The exercise was repeated two to three times for each muscle group for 20 minutes. Practice was accompanied by listening to soothing music. The defects of the samples in performing the exercises were solved with the help of a researcher.
Category
Treatment - Other
2
Description
Distance education group: Pregnant women with hypothyroidism were asked to carefully view and implement the educational content that the researcher has already prepared for them and sent to the WhatsApp group at home. This group also performed the movements twice a week and sent some of their movements as a video to the researcher. Exercise was repeated for each muscle group two to three times for 20 minutes. Practice was accompanied by listening to soothing music. Exercises were followed up by the researcher on a weekly basis through phone calls and messages on WhatsApp, and the problems in performing the exercises were solved.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hassan Asgari (AS) Health Center in Najafabad
Full name of responsible person
fateme Nasaj
Street address
Health Alley, Imam Street, Najafabad.
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۳۶۸۴۹۶۱
Phone
+98 31 4274 4246
Email
najafabad-health@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mansoore Ahmadi Faraz
Street address
University Blvd, Najafabad.
City
Najafabad
Province
Isfehan
Postal code
851413131
Phone
+98 913 168 1369
Email
2021ahmadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mina Jouzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University Blvd, Najafabad.
City
Najafabad
Province
Isfehan
Postal code
851413131
Phone
+98 31 4229 2581
Email
minajouzi@pnu.iaun.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mina Jouzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University Blvd, Najafabad.
City
Najafabad
Province
Isfehan
Postal code
851413131
Phone
+98 31 4229 2581
Email
minajouzi@pnu.iaun.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afsane Emanian
Position
MSc Student in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 23, Pamchal Dead End, Ehsan Alley, East Delgosha St, Najafabad.
City
Najafabad
Province
Isfehan
Postal code
8517779188
Phone
+98 31 4264 3000
Email
in.sodako@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