Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000270718
Ethics application status
Approved
Date submitted
7/04/2021
Date registered
14/02/2022
Date last updated
14/02/2022
Date data sharing statement initially provided
14/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Yoga and Theta Healing on Symptoms of Primary Dysmenorrhea
Scientific title
Effect of Yoga and Theta Healing on Symptoms of Primary Dysmenorrhea: Sample of university students aged 18-25
Secondary ID [1] 301179 0
Nil known
Universal Trial Number (UTN)
U1111-1245-7980
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Dysmenorrhea 317314 0
Condition category
Condition code
Alternative and Complementary Medicine 315432 315432 0 0
Other alternative and complementary medicine
Alternative and Complementary Medicine 321627 321627 0 0
Spiritual care
Reproductive Health and Childbirth 322449 322449 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Yoga will be applied to Group 1 and Theta Healing® to Group 2 for 6 months with a researcher.
Based on researcher training in practitioner yoga and ThetaHealing for Group 1 yoga program designed by researcher, for Group 2 ThetaHealing program designed by researcher,
Group 1 will do yoga 2 days a week 40-45 minutes, live online group classes, low level of intensity designed for healthy people by a researcher. The program has been prepared based on simple pregnancy yoga practices so that everyone can easily apply it. After the program 3. months and 6. months participants will check by questionnaire and scales.
Group 2 will do ThetaHealing 2 days a week 15-30 minutes live online individual interviews. ThetaHealing is a meditation to remove negative emotions. Negative feelings are determined by talking to the participant. Determined negative emotions are tried to be reduced through meditation. After the program 3. months and 6. months participants will check by questionnaire and scales.The researcher will make the intervention.
The yoga and ThetaHealing program will be done online 2 days a week for 6 months.[ Online live platform ( live online at participant’s home or any place where the participant can easily perform )]
Intervention code [1] 317486 0
Behaviour
Comparator / control treatment
Group 3 will maintain their routine habits for dismenore (For example: take a painkiller, massage, lie down and sleep, using hot water bag etc.)
Control group
Active

Outcomes
Primary outcome [1] 324085 0
Primary outcome 1: Evaluation of change in dysmenorrhea with yoga (composite outcome). Dysmenorrhea Affectation Scale (DAC) and Negative Mood Regulation Expectancies Scale (NMR) will be used.
Timepoint [1] 324085 0
Timepoint: 3rd and 6th months (primary time point) after randomization
Primary outcome [2] 329392 0
Primary outcome 3: Evaluation of change in dysmenorrhea with ThetaHealing (composite outcome). Dysmenorrhea Affectation Scale (DAC) and Negative Mood Regulation Expectancies Scale (NMR) will be used.
Timepoint [2] 329392 0
Timepoint: 3rd and 6th months (primary time point) after randomization
Secondary outcome [1] 383716 0
Nil
Timepoint [1] 383716 0
Nil

Eligibility
Key inclusion criteria
primary dysmenorrhoea problem among midwifery students at a university's faculty of health sciences
Minimum age
19 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Change in menstruation characteristics (cycle time, menstruation time, bleeding amount, etc.) after diagnosis of dysmenorrhea.
- Having a chronic or physical illness that prevents yoga.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/04/2021
Date of last participant enrolment
Anticipated
Actual
3/05/2021
Date of last data collection
Anticipated
Actual
22/11/2021
Sample size
Target
90
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 22668 0
Turkey
State/province [1] 22668 0
Istanbul

Funding & Sponsors
Funding source category [1] 305629 0
Self funded/Unfunded
Name [1] 305629 0
No funding.
Country [1] 305629 0
Primary sponsor type
Individual
Name
Ayfer Eser
Address
Kütahya University of Health Sciences, Faculty of Health Sciences, Department of Midwifery, Evliya Çelebi Campus Tavsanli Road 10. Km Kütahya
Country
Turkey
Secondary sponsor category [1] 306036 0
None
Name [1] 306036 0
None
Address [1] 306036 0
None
Country [1] 306036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305918 0
Istanbul Üniversity-Cerrahpasa Non-Interventional Research Ethics Committee
Ethics committee address [1] 305918 0
Istanbul University-Cerrahpasa Rectorate, 34320 Avcilar-Istanbul
Ethics committee country [1] 305918 0
Turkey
Date submitted for ethics approval [1] 305918 0
30/12/2020
Approval date [1] 305918 0
12/01/2021
Ethics approval number [1] 305918 0
2020/56

Summary
Brief summary
This study was planned in a randomized controlled experimental type to determine the effect of yoga and Theta Healing® on primary dysmenorrhea symptoms.
Research hypothesis:
1. H1 hypothesis: Yoga has a healing effect on symptoms of primary dysmenorrhea.
2. H1 hypothesis: Theta Healing® has a healing effect on symptoms of primary dysmenorrhea.
The dependent variable of the research is primary dysmenorrhea, the independent variables of the research are yoga and Theta Healing®.
This study is a two-stage study. The first study was carried out to determine the dysmenorrhea problem of midwifery students in a university health sciences faculty and the factors affecting it, and students with dysmenorrhea were identified in the department. In the second study, the effect of yoga and Theta Healing® applied to students with primary dysmenorrhea problem will be investigated.
The universe of the study will be those with primary dysmenorrhea among midwifery students at a university health sciences faculty.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102058 0
Miss Ayfer Eser
Address 102058 0
Istanbul University-Cerrahpasa Faculty of Health Science Department of Midwifery
Büyükçekmece Campus, Alkent 2000 Neighborhood, Yigittürk Street, No:5/9/1

Büyükçekmece/Istanbul
Country 102058 0
Turkey
Phone 102058 0
+90 0536 825 25 69
Fax 102058 0
Email 102058 0
[email protected]
Contact person for public queries
Name 102059 0
Nurten Kaya
Address 102059 0
Istanbul University-Cerrahpasa Faculty of Health Science Department of Midwifery
Büyükçekmece Campus, Alkent 2000 Neighborhood, Yigittürk Street, No:5/9/1

Büyükçekmece/Istanbul
Country 102059 0
Turkey
Phone 102059 0
+90 212 866 37 00
Fax 102059 0
Email 102059 0
[email protected]
Contact person for scientific queries
Name 102060 0
Ayfer Eser
Address 102060 0
Istanbul University-Cerrahpasa Faculty of Health Science Department of Midwifery
Büyükçekmece Campus, Alkent 2000 Neighborhood, Yigittürk Street, No:5/9/1

Büyükçekmece/Istanbul
Country 102060 0
Turkey
Phone 102060 0
+90 0536 825 25 69
Fax 102060 0
Email 102060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11300Informed consent form  [email protected]
11301Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.