EFFECTIVENESS OF YOGA ON QUALITY OF LIFE AND PSYCHOLOGICAL DISTRESS AMONG FAMILY CAREGIVERS OF PATIENTS WITH CANCER

Registration number: NPCTR2021000017
Register By : Neelu Aryal
Registered Date : 2021/09/13
Email : neeluaryal02@gmail.com
Titles & IDs
Refrence Number : REF/2021/09/000073
Public Title : EFFECTIVENESS OF YOGA ON QUALITY OF LIFE AND PSYCHOLOGICAL DISTRESS AMONG FAMILY CAREGIVERS OF PATIENTS WITH CANCER
Scientific Title : EFFECTIVENESS OF YOGA ON QUALITY OF LIFE AND PSYCHOLOGICAL DISTRESS AMONG FAMILY CAREGIVERS OF PATIENTS WITH CANCER
Trial Acronyms :
Registration Type : Prospective
Secondary Id : neeluaryal02@gmail.com
Recruitment Country : Nepal

Cancer seems to be among the leading causes of morbidity and mortality. According to World Health Organization (WHO), in 2018, 9.6 million people died of cancer and 70% were from middle and low‒income countries. It is the second most common disease in many countries which not only threatens death but also affects the structure and function of families. In our life, Care giving and care receiving can occur at any point. It is typically associated with chronic illnesses or disabilities which lead to loss of independence and disturbance in proper day-to-day functioning of the caregiver. Care giving tasks are found to be unpleasant and also physically demanding which may often cause a disruption in familial roles and the activities of the caregiver. Cancer family Caregivers are a group which needs more of attention, research, and interventions focusing on their unique healthcare needs such as psychological and emotional distress, personal care or medical issues and unmet activity needs. Yoga originates from the term “yuj". In Sanskrit it’s meaning is "to yolk or to unite". It means union of the individual consciousness or soul with the Universal Consciousness or Spirit. It has become a popular practice for health maintenance and illness recovery in the global community. Objective of the study is to assess the quality of life and psychological distress among cancer family caregivers, to find out the effect of yoga intervention on quality of life and psychological distress among those cancer family caregivers randomized to interventional group compared to non interventional group, to explore cancer family caregiver experience of participating in yoga. Research Design and method: Mixed method will be used. Both quantitative and qualitative data will be used to find the result. In the quantitative part of the study, Cross sectional design will be used to find out the quality of life and psychological distress among caregiver of patients with cancer in the first phase and true experimental pretest-posttest design will be used in the second phase. In the second phase, it will be a randomized controlled trial with an intervention group and a non interventional group with a 50/50 allocation ratio. Randomization will be done from those family caregivers with poor quality of life and psychological distress from the first phase of the study. The intervention for the non interventional group will be hold till the data for the study are collected. In the qualitative part, phenomenological approach will be used to collect the data from the family caregivers of patient with cancer i.e their experience of participating in yoga. Bhaktapur Cancer Hospital, Bhaktapur, will be taken as place of study. The SF-36 short-form health survey will be used to find out the quality of life. Kessler Psychological Distress Scale-6 will be used to find the psychological distress.

Principal Investigator (Trail coordinator for multi centric study)

Principal Investigator ( 1 )

Name
Neelu Aryal
Email
neeluaryal02@gmail.com
Contact No
9846036977
Designation
PhD student
Orgnizational Affilation
Zhengzhou university, School of Nursing and health, Henan, China
Address
Bharatpur-11, Chitwan, Nepal
Country
Nepal

Contact person (scientific query)
Name
Neelu Aryal
Email
neeluaryal02@gmail.com
Contact No
9846036977
Designation
PhD student
Orgnizational Affilation
Zhengzhou university, School of Nursing and health, Henan, China
Address
Bharatpur-11, Chitwan, Nepal
Country
Nepal

Contact person (Public Query)
Name
Neelu Aryal
Email
neeluaryal02@gmail.com
Contact No
9846036977
Designation
PhD student
Orgnizational Affilation
Zhengzhou university, School of Nursing and health, Henan, China
Address
Bharatpur-11, Chitwan, Nepal
Country
Nepal

Contact person (Public Query)
Name
Neelu Aryal
Email
neeluaryal02@gmail.com
Contact No
9846036977
Designation
PhD student
Orgnizational Affilation
Zhengzhou university, School of Nursing and health, Henan, China
Address
Bharatpur-11, Chitwan, Nepal
Country
Nepal

Sponsor
Type
Others (Please specify)
Name
Neelu Aryal
Email
neeluaryal02@gmail.com
Contact
9846036977
Address
Bharatpur-11, Chitwan, Nepal

Recruitment Country
Country
Nepal

Site(s) of study
Site Address
Bhaktapur Cancer Hospital, Bhaktapur, Nepal
Contact Person Name
Neelu Aryal
Contact Person Email
neeluaryal02@gmail.com
Contact Person Contact
9846036968

Ethics Committees Informations
Ethics Committee
Nepal Health Research Council
Ethics Committee Contact
014254220
Ethics Committee Address
Ram Shah path, Kathmandu
Ethics Committee Email
nhrc@nhrc.gov.np

Approvals
Status
Submitted/ Under review
Date
2021-07-05

Health condition(s)
Status
Particular health condition(s) or problem(s)

Study type
Thesis
Yes
Type of trial
Interventional
Study Type
Others (Specify),

Study Design
Allocation
randomized controlled trial
Masking
blinded (masking used)
Assignment
single
purpose
prevention
Trial Phase
N/A

Intervention and comparison
Intervention name
Yoga intervention
Intervention details

Objective of the study is to assess the quality of life and psychological distress among cancer family caregivers, to find out the effect of yoga intervention on quality of life and psychological distress among those cancer family caregivers randomized to interventional group compared to non interventional group, to explore cancer family caregiver experience of participating in yoga. Research Design and method: Mixed method will be used. Both quantitative and qualitative data will be used to find the result. In the quantitative part of the study, Cross sectional design will be used to find out the quality of life and psychological distress among caregiver of patients with cancer in the first phase. The study population is family caregivers of patients with cancer. Using simple random sampling 384 family caregivers will be selected using inclusion and exclusion criteria. Quality of life and Psychological distress will be assessed using the tool (SF-36 and K6) respectively. Then in the second phase of the study true experimental pretest-posttest design will be used. Those family caregivers with poor quality of life and psychological distress from the first phase of the study, using RCT (randomizartion, blind and matching) is divided into intervention group and non interventional group i.e Control with a 50/50 allocation ratio. Interventional group is given yoga intervention while non interventional group i.e control is not given any intervention. The intervention for the non interventional group will be hold till the data for the study are collected and participants on the non interventional group will be informed that they will be provided with yoga intervention after the wait period of 12 weeks. Random allocation of participants to interventional and non interventional group will be done in a multiphase manner by using a random number table by the staff independent of research team. Randomization allocation will be concealed using sealed envelopes. In the second phase for randomized control trial, single blinding will be done. participants (family caregivers) will be blinded during randomization of group. Those allocated to yoga group will be given intervention within 1 week of their allocation and those allocated to non interventional group will be informed that they will be provided yoga after 12 weeks. Matching: In the both group age group will be match and 50/50 allocation ratio to interventional and non interventional group from the data will be obtained from second part of the study (i.e. RCT) with those who have poor quality of life and Psychological distress. Data collection will be done by 5 research assistant (Nursing staff, who has passed Bachelor degree in nursing) and researcher in both the phase of the study (i.e. cross sectional and interventional). Questionnaire with interview technique will be used. The purpose of the study will be explained to the respondents. Yoga intervention will be provided for 12 weeks (3 months). There will be four session of yoga in a week. For the first 6 weeks, two session of yoga is given by a yoga instructor in Bhaktapur cancer hospital, Bhaktapur, Nepal. and for remaining two session, it will be adviced to practice themselves. For the remaining 6 weeks, it will be adviced to practice yoga, four session in a week themselves. Yoga protocol developed consists of loosening exercises, Asanas, pranayamas, meditation and deep relaxation technique. The session of yoga takes 60 minutes to complete.

Comparison name
Family caregivers of patients with cancer
Comparison details

Family caregivers of interventional group will be provided with yoga intervention for 12 weeks while family caregivers of non interventional group i.e control group will be not be provided with any intervention until the yoga intervention is completed for interventional group and results between interventional and non interventional group i.e control is compared. Then same yoga intervention will be provided for non interventional group i.e control group after the wait period of 12 weeks.


Eligibility (Inclusion criteria)
Age Group
18 to 60 years
Gender
Both
Detail

The inclusion criteria of this study will be:-

  • Family caregivers:
  • who are currently providing physical and/or psychological support to a cancer patient.

    whose age is 18 to 60 years.

    who are not planning to move to other place in next 12 months.

    who are willing to attend the yoga classes and practice yoga themselves as per advice.

    who are free from any medical conditions that prevent participation in the yoga program.

    who can speak Nepali.

    Exclusion Detail

    The exclusion criteria in this study will be

  • Family caregivers providing care to a child with cancer.
  • Family caregivers who have previously care for a cancer patient and who has now died.
  • Family caregiver who cannot attend the group yoga classes and cannot practice yoga as per advice.
  • Family caregivers who report to have severe psychiatric, neurological or orthopedic disorders.
  • Family caregivers who are practicing yoga/relaxation techniques/physical exercise regularly for past 1 month.
  • Family caregiver older than 60 years.
  • Family caregiver who are pregnant or recently gave birth.
  • Sample Size
    1)In quantitative study A) For cross sectional part (first phase of the study): Sample size: 384 It calculated on the basis of the study conducted by Martin AC, Keats MR Impact of Yoga on QOL and Psychological Distress. B)For Randomized control trial (sec
    Enrollment Date
    2021-10-01
    Completion Date
    2022-04-30
    Enrollment Status
    Pending