Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398990
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-03
Brief Title:
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Sponsor:
Acibadem University
Organization:
Acibadem University
Study Overview
Official Title:
The Effect of Telerehabilitation-Based Cognitive Exercise Therapy Approach and Yoga on Pain Physical Function and Quality of Life in Adolescents With Dysmenorrhoea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dysmenorrhoea is a condition that negatively affects the quality of life in women of many age groups In girls with dysmenorrhoea in adolescence there is an effect on school performance self-confidence-depression problems and a decrease in quality of life due to pain In order to eliminate these negative effects they should receive a good treatment Medical treatment usually tries to minimise and balance this situation Considering the fact that families do not want to use drugs such as oral contraceptives in their children at this age and the risks of oral contraceptives parents are in different searches Considering that the approach to pain should always be from a holistic perspective yoga and cognitive exercise therapy approaches are both biopsychosocial treatment methods within the scope of mind-body integrity Yoga and cognitive exercise therapy approach is thought to reduce symptoms improve physical functions and quality of life in adolescent girls With these positive effects school absenteeism decreases depression and self-confidence improve Health costs will also be reduced to some extent
Detailed Description:
This study was designed as a prospective randomised controlled parallel group study
The population of the study consisted of patients who applied to gynaecology and obstetrics specialists in Istanbul
G-Power Statistical and Qualitative Data Analysis Software version 3192 was used to estimate the sample size required for the study Considering that the study consisted of a total of three parallel groups to be measured at three different time points and the effect size f025 α error level 005 power 1-β error level 080 the total sample size was calculated as 36 When the estimated rate of subjects who might be lost to follow-up was taken as 20 it was calculated that at least 45 subjects should be included in the study
The 1st intervention group will receive cognitive exercise therapy approach the 2nd intervention group will receive yoga and the 3rd control group will consist of people receiving routine medical treatment In order to fully demonstrate the effectiveness of the interventions to reduce bias and to ensure homogeneity between the training and control groups the allocation to the groups will be determined in the randomiser org programme
Yoga and cognitive exercise therapy approach will be applied by a physiotherapist who has training in both fields Treatments will continue twice a week for 12 weeks After the initial assessment of the cases one-to-one face-to-face trainings will be carried out in the first week 2 sessions in order to ensure their compliance with the treatment and to fully understand the treatment method Afterwards treatments will be carried out synchronously with the patients 2 times a week via the online platform Zoom
Evaluations will be carried out 3 times as pre-treatment 6th week and 12th week All evaluations will be made face-to-face in the relevant clinic
The population of the study consisted of patients who applied to gynaecology and obstetrics specialists in Istanbul
G-Power Statistical and Qualitative Data Analysis Software version 3192 was used to estimate the sample size required for the study Considering that the study consisted of a total of three parallel groups to be measured at three different time points and the effect size f025 α error level 005 power 1-β error level 080 the total sample size was calculated as 36 When the estimated rate of subjects who might be lost to follow-up was taken as 20 it was calculated that at least 45 subjects should be included in the study
The 1st intervention group will receive cognitive exercise therapy approach the 2nd intervention group will receive yoga and the 3rd control group will consist of people receiving routine medical treatment In order to fully demonstrate the effectiveness of the interventions to reduce bias and to ensure homogeneity between the training and control groups the allocation to the groups will be determined in the randomiser org programme
Yoga and cognitive exercise therapy approach will be applied by a physiotherapist who has training in both fields Treatments will continue twice a week for 12 weeks After the initial assessment of the cases one-to-one face-to-face trainings will be carried out in the first week 2 sessions in order to ensure their compliance with the treatment and to fully understand the treatment method Afterwards treatments will be carried out synchronously with the patients 2 times a week via the online platform Zoom
Evaluations will be carried out 3 times as pre-treatment 6th week and 12th week All evaluations will be made face-to-face in the relevant clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None