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Evaluation of short-term and long-term effects of yoga with music on beta-endorphin, serotonin, body composition, stress and depression of inactive obese women

Protocol summary

Study aim
Simultaneous effect of yoga and music on beta-endorphin and serotonin levels and comparison of short-term and long-term effects of music on these levels in inactive obese women
Design
Clinical trial with control group, with parallel groups, randomized, phase 2 on 28 patients. Excel software rand function was used for randomization.
Settings and conduct
Based on the online call in sports clubs, 28 people will be selected voluntarily and randomly in 3 groups, 8 people and 1 group of 4 people (control) as a statistical sample. The subjects are not aware of randomization and the clinical caregivers, outcome assessors, data analysts, identify the subjects by code, and analyze the subjects in the order of the table numbers through a pre-coded table. 48 Before the start of training, pre-test evaluations were performed, after the first training session, the second blood sample was taken, and finally, the third blood sample was taken to assess the duration after 6 weeks of training (or music) intervention.
Participants/Inclusion and exclusion criteria
Body mass index equal to or greater than 30 kg / m2, age group 25-45 years, no regular exercise in the past 6 months, no metabolic diseases and no medication or exercise supplements in the past month.
Intervention groups
48 hours before the start of the exercises, we had pre-test evaluations for all intervention groups (first, second, third, control), immediately after the first yoga practice session with music (first group), yoga practice without music (second group), Listening to music without practicing yoga (group 3) and the control group, we had a second blood sample and finally, after 6 weeks, we had a third blood sample for all intervention groups.
Main outcome variables
Beta-endorphin levels, serotonin levels, body composition, anxiety changes and depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220304054178N1
Registration date: 2022-06-20, 1401/03/30
Registration timing: registered_while_recruiting

Last update: 2022-06-20, 1401/03/30
Update count: 0
Registration date
2022-06-20, 1401/03/30
Registrant information
Name
Setareh Ghaderi
Name of organization / entity
The University of Kordestan
Country
Iran (Islamic Republic of)
Phone
+98 87 3624 8158
Email address
starehartan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-25, 1401/03/04
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
2022-05-25, 1401/03/04
Actual recruitment end date
2022-08-11, 1401/05/20
Trial completion date
2022-08-11, 1401/05/20
Scientific title
Evaluation of short-term and long-term effects of yoga with music on beta-endorphin, serotonin, body composition, stress and depression of inactive obese women
Public title
The effects of yoga and music on beta-endorphin, serotonin, body composition, anxiety and depression in obese obese women
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Obese women with a body mass index equal to or higher than 30 kg per square meter. Age group 25-45 years.
Exclusion criteria:
Not having sufficient BMI of the subjects Lack of interest in yoga and music Lack of motivation of subjects in performing clinical trials Not enough time by the subjects to do the test
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 1
Each participant provides a sample to study.
Actual sample size reached: 28
More than 1 sample in each individual
Actual sample size in each individual: 1
Each participant provides a sample to study.
Randomization (investigator's opinion)
Randomized
Randomization description
To perform the simple randomization method, we used the card shuffling method. In this method, a number of cards selected by the researcher from 1 to 28 were written on each card. For example, by removing the cards, we took out a card and registered its number as the first group and took the card out of the basket, this process until we reach a random sequence according to the sample size (n = 8) for the group. The first continued. The procedure was the same for all groups. In order to hide the random allocation, we used the central randomization method. In this method, the card numbers were given to two yoga instructors in two separate clubs and they were sampled in these two clubs at the same time based on the order of participants's study, and the researcher contacted the relevant clubs about random allocation. The participant asked a specific group, using the telephone.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The first and second groups practice yoga in the hall air for 23 to 24 degrees Celsius for 6 weeks and three sessions (60 to 90 minutes) per week (18 sessions). After the pre-test, the Hatayoga training program will be performed. Before starting the exercises, the trainer will devote 15 minutes to general warm-up, then 15 to 30 minutes of asanas (physical exercises), pranayama (breathing exercises) and finally 15 minutes, meditation or shavasana (relaxation). will be.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University
Street address
No. 4, Shadab Alley, Sheikh Mazhar St., Shahrak Daneshgah St., Saqez, Kurdistan
City
Saqez,
Province
Kurdistan
Postal code
6681685563
Approval date
2022-01-08, 1400/10/18
Ethics committee reference number
IR.UOK.REC.1400.032

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Beta endorphin
Timepoint
Before the start of the course (48 hours before), 2 days and 42 days after the start of the course
Method of measurement
Human Beta-Endorphin, ELISA Kit

2

Description
Serotonin
Timepoint
Before the start of the course (48 hours before), 2 days and 42 days after the start of the course
Method of measurement
Human Serotonin, ELISA Kit

3

Description
Body composition
Timepoint
Start of study (before training), end of study (after last training session)
Method of measurement
Bioelectric impedance analyzer

4

Description
Changes in anxiety and depression
Timepoint
Start of study (before training), end of study (after last training session)
Method of measurement
Physical, Mental and Social Health Questionnaire, General Health Questionnaire, Eising Self-Esteem Questionnaire, Beck Depression Inventory, Beck Anxiety Inventory.

5

Description
Changes in depression
Timepoint
Start of study (before training), end of study (after last training session)
Method of measurement
Physical, Mental and Social Health Questionnaire, General Health Questionnaire, Eising Self-Esteem Questionnaire, Beck Depression Inventory, Beck Anxiety Inventory

Secondary outcomes

1

Description
Obesity
Timepoint
The first measurement before the first blood draw and the last measurement before the third blood draw
Method of measurement
Use of bioelectric impedance analyzer

Intervention groups

1

Description
The first intervention group: 48 hours before the start of training, pre-test evaluations, immediately after the first session of yoga practice with music, the second blood draw and finally, to evaluate the long-term effects of yoga and music, after 6 weeks of training intervention with We had the music of the third blood draw.
Category
N/A

2

Description
Second intervention group: 48 hours before the start of exercises, pre-test evaluations, immediately after the first session of yoga practice without music, second blood draw and finally, to evaluate the long-term effects of yoga and music, after 6 weeks of practice intervention without We had the music of the third blood draw.
Category
N/A

3

Description
Third intervention group: 48 hours before training, pre-test evaluations, 48 hours after, immediately after listening to music without training intervention, second blood sampling and finally, to evaluate the long-term effects of music after 6 weeks of blood We had the third one.
Category
N/A

4

Description
Control group: 48 Before the start of the course, we had pre-test evaluations. After 48 hours, we performed a second blood sample and evaluation, and finally, after 6 weeks, we performed a third blood sample or evaluation. This group has no sports activities and continued their daily life.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Laboratory
Full name of responsible person
Anwar Bahrami Azar
Street address
Shafa Laboratory, Kurdistan Boulevard, Bukan City, East Azerbaijan
City
Bukan
Province
East Azarbaijan
Postal code
5951757558
Phone
+98 44 4622 5858
Fax
+98 44 4624 3451
Email
shafalab@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Kordestan
Full name of responsible person
Jamal Mohammadi
Street address
University of Kurdistan, Pasdaran Boulevard, Sanandaj, Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
1517566177
Phone
+98 87 3366 4600
Fax
+98 21 6600 0021
Email
info@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kordestan
Proportion provided by this source
10
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
The University of Kordestan
Full name of responsible person
Stareh Ghaderi
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
No. 4, Shadab Alley, Sheikh Mazhar St., University Town, Saqez County, Kurdistan Province
City
Saqqez
Province
Kurdistan
Postal code
6681685563
Phone
0098 836248158
Email
starehartan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Kordestan
Full name of responsible person
Dariush Shaykh al-Islami Watani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University of Kurdistan, Pasdaran Boulevard, Sanandaj, Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
1517566177
Phone
+98 87 3366 4600
Fax
+98 21 6600 0021
Email
d.vatani@uok.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Kordestan
Full name of responsible person
Stareh Ghaderi
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
No. 4, Shadab Alley, Sheikh Mazhar St., University Town, Saqez County, Kurdistan Province ۴
City
Saqqez
Province
Kurdistan
Postal code
6681685563
Phone
+98 87 3624 8158
Email
starehartan@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
In the form of informed consent, the first paragraph was about the confidentiality of patients' personal information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Data on study outcomes can be published after being unidentifiable.
When the data will become available and for how long
2022/10/22
To whom data/document is available
All researchers have approved proposals for meta-analysis.
Under which criteria data/document could be used
To conduct meta-analysis studies
From where data/document is obtainable
Address: No. 4, Setareh Ghaderi, Shadab Alley, Sheikh Mazhar St., University Town, Saqez, Kurdistan Province Postal Code 6681685563 Phone 0098 4815887362 Mobile +98 992 772 6504 Email starehartan@gmail.com
What processes are involved for a request to access data/document
The request is accompanied by a letter approving the meta-analysis
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