Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367023
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-29
Brief Title:
Effectiveness of Brahma Kumaris Raja Yoga Meditation on Quality of Life of Youth in the Deaddiction Center of Biratnagar
Sponsor:
Manipur International University
Organization:
Manipur International University
Study Overview
Official Title:
Effectiveness of Brahma Kumaris Raja Yoga Meditation on Quality of Life of Youth Residing in the Deaddiction Center of Biratnagar
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Drug addiction is a public health problem mainly youths are involved in the addiction and the major reason were due to peer pressure Spiritual meditation is thought to foster a deeper sense of meaning which creates new sources of positive reinforcement increasing motivation for alternative behavior patterns such as entering treatment or maintaining abstinence Cluster Randomized Control Trial will be performed for 1-year period where mixed method study design will be performed The major variables will be Anxiety and depression score Happiness index Quality of life Rate of Relapse Age Gender Occupation Education Income Family Size Family Income Family support Social status- HighMiddleLow History of drug use self Types of drugs Duration of usage Reason of drug use how they have started Amount of drugs Frequency of use Family history of drug use Money spent on drugs per month A modified validated Questionnaire will be used CRCT will be done by CONSORT Guidelines A total of 160 samples will be taken 40 from each center two were given Meditation intervention and 80 were given standard treatment as a control group and 16 qualitative interviews will be taken 4 from each center The intervention will be given for 3 months for 6 days one hour per day Rajyoga meditation basic course will be provided followed by a 1-hour daily spiritual lesson Positive thinking and motivation classes will be provided to the intervention group and in the control group standard treatment will be given Follow-up will be done after 1 month of discharge from the rehabilitation centers Ethical clearance will be taken from the Ethical Review Board ERB of the Nepal Health Research Council NHRC This study will be useful for developing policy and practice in rehabilitation centers to apply the technique of Rajyoga Meditation in relapse prevention
Detailed Description:
Introduction Globally 24 million people were current drinkers In 2020 223 of the worlds population used tobacco 367 of men and 78 of women Around 80 of the 13 billion tobacco users worldwide live in low- and middle-income countries
The problem of Substance usedrug use in Nepali society has traditionally been dominated by cannabis and opioids But this list has now expanded to include hard drugs like the South Asian cocktail which is a mixture of opioids benzodiazepine and antihistamines Heroin Diacetyl morphine injectable buprenorphine and pharmaceutical opioids is currently known to be frequently used opioids in Nepal
The reason for starting drug use was mainly due to peer pressure 89 recreation 72 and curiosity 62 Fifteen percent of the drug users suffer from Hepatitis BC 36 are from lower secondary education and 39 of drug users are unemployed Due to this various personal professional and social problem arises The drug users have expectations from the government 39 said cross-border screening and checking to reduce drug use and 47 said there should be employment opportunities to improve the lives of drug users
Despite this huge problem only one in seven people with drug users receive treatment
Different rehabilitation centers in Nepal are led by NGOs and some are privately run
Rehabilitation centers help to enhance self-confidence among drug abusers and enable them to dislike drugs to create public awareness in society via various programs showing the ill effects of the drugs It helps to decrease the criminal activities caused by drug addiction to decrease the consumption of the drugs by the users and also to control the import and export of drugs
Spiritual meditation is thought to foster a deeper sense of meaning which creates new sources of positive reinforcement increasing motivation for alternative behavior patterns such as entering treatment or maintaining abstinence
Meditation techniques may offer additive benefits to standard outpatient treatment compared to standard treatment alone specifically in maintaining abstinence
Short-term spiritual-based relaxation therapy Rajyoga meditation was highly effective in causing earlier relief in chronic tension headaches If we can change our thinking ahara vihara then we will be able to change the quality of life
Rationale of the study Youths are the future of the Nation The literature shows that spirituality and Brahmakumaris Raja Yoga meditation is effective in reducing anxiety and helpful for Coronary heart diseases There are very few studies that show the Impact of yoga and physical exercise on psychological wellbeing among substance abusers but very limited studies show the effects of Raja Yoga meditation to improve relapse prevention in Nepal Hence the aim to measure the effects of Raja Yoga Meditation among youths who are residing in rehabilitation centers of Biratnagar These findings will help develop a policy to implement spiritual-based practice to improve the quality of life and reduce relapse prevention
Hypothesis H0 There is no difference in relapse prevention between Rajyoga meditation along with rehabilitation center treatment and rehabilitation center treatment alone
4 General Objective To find out the Prevalence of anxiety depression score happiness index and quality of life among people residing in rehabilitation centers To explore the life experiences of youth residing in the rehabilitation centers before and after the meditation program
To find out the effect of Brahma Kumaris Raja Yoga meditation on relapse prevention and improving the quality of life of youth residing in the selected Rehabilitation center of Biratnagar
Study Variables Outcome variables Primary outcome Depression Anxiety and Stress Secondary outcome Rate of Relapse Independent variables Age Gender Occupation Education Income Family Size Family Income Family support
Social status- HighMiddleLow History of drug use self Types of drugs Duration of usage
Reason of drug use How you have started Amount of drugs Frequency of use Family history of drug use Money spent on drugs per month Methodology Research Methods Mixed Data collection Data will be collected for baseline after 3 months and 1 month after discharge from the rehabilitation center Study site and its justification Biratnagar Metropolitan City
Specify type of study Cluster Randomized Controlled Trial CRCT Sample size Total 409 3694010 nonresponse assuming 60 prevalence of relapse as per the studyKabisa- 2021 For intervention 160 40 from each center two was given Meditation intervention and 80 were given standard treatment as control group 16 qualitative interview will be taken 4 from each center Sampling technique From the list of rehabilitation centers two rehabilitation centers will be selected randomly for the intervention group and two for the control group by lottery method
CRCT will be done by CONSORT Guidelines Period of study 1 year Method of randomization Simple randomization the clusters will be randomized to the intervention or control arm
Intervention 3 months for 6 days one hour per day Rajyoga meditation basic course will be provided followed by one-hour daily spiritual lesson Positive thinking and motivation classes will be provided to the intervention group where Experimental population All youths residing in the rehabilitation center and who are under treatment of different rehabilitation centers of Biratnagar Metropolitan city
Study unit Individual youth residing in rehabilitation centers Inclusion criteria Those youth more than 18 years old who had used drugs and residing in the rehabilitation center of Biratnagar and giving consent will be involved in the study
Data collection Technique Face-to-face interview and in-depth interviews will be used for qualitative study
Ethical consideration Ethical clearance will be taken from the Ethical Review Board ERB of Nepal Health Research Council NHRC and Manipur International University Data collection tools A modified validated Questionnaire will be used WHOQOL-SRPB field-test instrument World Health Organization had developed the tools to measure the quality of life spirituality religiousness and personal beliefs SRPB -32 items
The data will be categorized by Cut off-point Determinants of drug abuse A pretesting will be conducted to measure the appropriateness of the questionnaire and the time taken to complete it Piloting A pilot study will be done in one of the rehabilitation centers at Lahan to find out the feasibility and acceptability of certain policies and to check whether there is any flaws
Analysis Plan Data integration Once both quantitative and qualitative data are analyzed separately we will compare the results from both and tie findings together
Expected outcome of the study The expected outcome of the effects of Brahamakumari Raj Yoga Meditation on the quality of life of youth residing in the rehabilitation center of Biratnagar include the current situation of anxiety depression and quality of life and how meditation helps reduce relapse
Significance and Contribution This study will be useful for developing policy and practice in rehabilitation centers to apply the technique of Rajyoga Meditation in relapse prevention and lead their life and health
The problem of Substance usedrug use in Nepali society has traditionally been dominated by cannabis and opioids But this list has now expanded to include hard drugs like the South Asian cocktail which is a mixture of opioids benzodiazepine and antihistamines Heroin Diacetyl morphine injectable buprenorphine and pharmaceutical opioids is currently known to be frequently used opioids in Nepal
The reason for starting drug use was mainly due to peer pressure 89 recreation 72 and curiosity 62 Fifteen percent of the drug users suffer from Hepatitis BC 36 are from lower secondary education and 39 of drug users are unemployed Due to this various personal professional and social problem arises The drug users have expectations from the government 39 said cross-border screening and checking to reduce drug use and 47 said there should be employment opportunities to improve the lives of drug users
Despite this huge problem only one in seven people with drug users receive treatment
Different rehabilitation centers in Nepal are led by NGOs and some are privately run
Rehabilitation centers help to enhance self-confidence among drug abusers and enable them to dislike drugs to create public awareness in society via various programs showing the ill effects of the drugs It helps to decrease the criminal activities caused by drug addiction to decrease the consumption of the drugs by the users and also to control the import and export of drugs
Spiritual meditation is thought to foster a deeper sense of meaning which creates new sources of positive reinforcement increasing motivation for alternative behavior patterns such as entering treatment or maintaining abstinence
Meditation techniques may offer additive benefits to standard outpatient treatment compared to standard treatment alone specifically in maintaining abstinence
Short-term spiritual-based relaxation therapy Rajyoga meditation was highly effective in causing earlier relief in chronic tension headaches If we can change our thinking ahara vihara then we will be able to change the quality of life
Rationale of the study Youths are the future of the Nation The literature shows that spirituality and Brahmakumaris Raja Yoga meditation is effective in reducing anxiety and helpful for Coronary heart diseases There are very few studies that show the Impact of yoga and physical exercise on psychological wellbeing among substance abusers but very limited studies show the effects of Raja Yoga meditation to improve relapse prevention in Nepal Hence the aim to measure the effects of Raja Yoga Meditation among youths who are residing in rehabilitation centers of Biratnagar These findings will help develop a policy to implement spiritual-based practice to improve the quality of life and reduce relapse prevention
Hypothesis H0 There is no difference in relapse prevention between Rajyoga meditation along with rehabilitation center treatment and rehabilitation center treatment alone
4 General Objective To find out the Prevalence of anxiety depression score happiness index and quality of life among people residing in rehabilitation centers To explore the life experiences of youth residing in the rehabilitation centers before and after the meditation program
To find out the effect of Brahma Kumaris Raja Yoga meditation on relapse prevention and improving the quality of life of youth residing in the selected Rehabilitation center of Biratnagar
Study Variables Outcome variables Primary outcome Depression Anxiety and Stress Secondary outcome Rate of Relapse Independent variables Age Gender Occupation Education Income Family Size Family Income Family support
Social status- HighMiddleLow History of drug use self Types of drugs Duration of usage
Reason of drug use How you have started Amount of drugs Frequency of use Family history of drug use Money spent on drugs per month Methodology Research Methods Mixed Data collection Data will be collected for baseline after 3 months and 1 month after discharge from the rehabilitation center Study site and its justification Biratnagar Metropolitan City
Specify type of study Cluster Randomized Controlled Trial CRCT Sample size Total 409 3694010 nonresponse assuming 60 prevalence of relapse as per the studyKabisa- 2021 For intervention 160 40 from each center two was given Meditation intervention and 80 were given standard treatment as control group 16 qualitative interview will be taken 4 from each center Sampling technique From the list of rehabilitation centers two rehabilitation centers will be selected randomly for the intervention group and two for the control group by lottery method
CRCT will be done by CONSORT Guidelines Period of study 1 year Method of randomization Simple randomization the clusters will be randomized to the intervention or control arm
Intervention 3 months for 6 days one hour per day Rajyoga meditation basic course will be provided followed by one-hour daily spiritual lesson Positive thinking and motivation classes will be provided to the intervention group where Experimental population All youths residing in the rehabilitation center and who are under treatment of different rehabilitation centers of Biratnagar Metropolitan city
Study unit Individual youth residing in rehabilitation centers Inclusion criteria Those youth more than 18 years old who had used drugs and residing in the rehabilitation center of Biratnagar and giving consent will be involved in the study
Data collection Technique Face-to-face interview and in-depth interviews will be used for qualitative study
Ethical consideration Ethical clearance will be taken from the Ethical Review Board ERB of Nepal Health Research Council NHRC and Manipur International University Data collection tools A modified validated Questionnaire will be used WHOQOL-SRPB field-test instrument World Health Organization had developed the tools to measure the quality of life spirituality religiousness and personal beliefs SRPB -32 items
The data will be categorized by Cut off-point Determinants of drug abuse A pretesting will be conducted to measure the appropriateness of the questionnaire and the time taken to complete it Piloting A pilot study will be done in one of the rehabilitation centers at Lahan to find out the feasibility and acceptability of certain policies and to check whether there is any flaws
Analysis Plan Data integration Once both quantitative and qualitative data are analyzed separately we will compare the results from both and tie findings together
Expected outcome of the study The expected outcome of the effects of Brahamakumari Raj Yoga Meditation on the quality of life of youth residing in the rehabilitation center of Biratnagar include the current situation of anxiety depression and quality of life and how meditation helps reduce relapse
Significance and Contribution This study will be useful for developing policy and practice in rehabilitation centers to apply the technique of Rajyoga Meditation in relapse prevention and lead their life and health
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