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The Effect of Yoga on Care Load, Quality of Life, and Psychological Well-Being of Indivıduals With Special Needs (Yoga)

Primary Purpose

Caregiver Burden, Quality of Life, Psychological Stress

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Yoga Practice
Ongoing caregivers
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver Burden focused on measuring yoga, Caregiver burden, Quality of Life, psychological well-being, individuals with special needs

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being between the ages of 18- 65,
  • Caring for an individual with special needs,
  • Absence of cognitive and physical dysfunction that would prevent doing yoga,
  • Agreeing to participate in the study and obtaining consent,
  • Having never done yoga before
  • Speaking Turkish,
  • The caregiver has internet access,
  • The caregiver has a computer/tablet/phone with a camera

Exclusion Criteria:

  • Having cognitive and musculoskeletal system, neuromuscular and chronic systemic diseases that prevent doing yoga,
  • Having had a surgical operation in the last 1 month,
  • Not being willing to participate in the study

Sites / Locations

  • Maltepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Technology-Supported Yoga Applied Group

Control Group

Arm Description

The yoga initiative to be applied to the intervention group; Yoga, which is mind-breath-body work; It includes meditation, pranayama (breath work), and asanas (yoga poses). The content of the yoga practice consists of the following poses: -Tadasana (Mountain pose), -Urdhvahastasana, -Uttanasana, -Ardha Uttanasana, -Plank, -Ashtang Pranam, -Bhujangasana (Mini cobra), -Adho Mukha Svanasana (Downward facing dog), -Vrksasana (Tree Pose), - Utthita Trikonasana (Triangle Pose), -Virabhadrasana I (Warrior I), -Virabhadrasana II (Warrior II), -Virabhadrasana I with Anjali Mudra (Hands Reverse Namaste), -Utkatasana (Chair Pose), -Salabhasana, -Paschimottanasana , -Dandasana, -Salamba Sarvangasana (Shoulder pose), -Ardha Urdhva Dhanurasana (Half Wheel Pose), -Reverse Warrior, -Child's pose, -Ananda Balasana (Happy baby), -Wipers, -Corpse Pose

No intervention was made in caregivers.

Outcomes

Primary Outcome Measures

Caregiver Burden Scale
The scoring of the 22-item scale is 1 (never), 2 (rarely), 3 (sometimes) and 4 (often) for each item. The total score of the scale ranges from 22 to 88. A maximum of 88 points can be obtained from the scale. The higher the score on the scale, the higher the burden of care is evaluated in the scale.
Multidimensional Quality of Life Scale (MILQ)
The MILQ questionnaire is a 35-item scale addressing 9 sub-dimensions. The answers in the scale are numbered from 1 to 7. 1 is expressed as "not at all satisfied" and "7" is expressed as "very satisfied". The total score of the scale varies between 35-245. Higher scores represent better functional status.
Warwick-Edinburgh Mental Well-Being Scale
It consists of 14 items, the scale is in 5-point Likert type and a minimum of 14 and a maximum of 70 points can be obtained from the scale. High scores from the scale indicate high mental (psychological) well-being.

Secondary Outcome Measures

Full Information

First Posted
January 20, 2022
Last Updated
June 8, 2022
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05218291
Brief Title
The Effect of Yoga on Care Load, Quality of Life, and Psychological Well-Being of Indivıduals With Special Needs
Acronym
Yoga
Official Title
the Effect of Technology Applıed Yoga on Care Load, Qualıty of Lıfe, and Psychologıcal Well-Beıng of Indıvıduals Wıth Specıal Needs
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The fact that an individual has a physical, social or mental disability affects not only the individual, but also the close environment of the individual and even the society in which he lives. Those who are most affected by this situation in the society are undoubtedly the caregivers. Caregivers of individuals with disabilities experience more anxiety than other caregivers, spare less time for themselves, and participate in less physical and social activities. As a result of social, physical and emotional burdens on parents and other caregivers of disabled individuals, low quality of life, unhealthy family function and negative psychological conditions are observed in caregivers, especially stress. Problems related to financial situation, exclusion from social environment, psychological state, sense of burnout and educational status are among the other problems experienced by caregivers. The aim of this study; The aim of this study is to examine the effects of technology supported yoga applied to caregivers of individuals with special needs on care burden, quality of life and psychological well-being. Research data will be collected from the caregivers of individuals with special needs registered in a Guidance and Research Center in a province. The data of the study will be collected using the Socio-demographic Data Collection Form, the Caregiver Burden Scale, the Multidimensional Quality of Life Scale, and the Warwick-Edinburgh Mental Well-Being Scale. The study is in a randomized controlled design. SPSS 25.0 program will be used in the data analysis of the research. Descriptive data will be analyzed using number, percentage, mean, standard deviations. Spearman test will be applied to determine the correlations between the scale scores. of groups Homogeneity in terms of descriptive statistics will be analyzed with the Kolmogorov Smirnov Test. Student t or Mann Whitney U tests will be used to compare numerical data in two independent groups, and One-way ANOVA or Kruskal Wallis tests will be used for comparisons in more than two independent groups. Relationships between categorical variables will be tested with chi-square test and relationships between numerical variables will be tested with correlation coefficient. The significance level will be accepted as 0.05. The power and effect size of the study will be calculated by regression analysis.
Detailed Description
Caregivers mostly consist of parents and even mothers. As primary caregivers in the care of a healthy newborn, mothers experience many physical, emotional and mental problems. Every parent makes plans for their child to be born, their social environment and their own expectations for their children are formed, and therefore, giving birth to a disabled child means that all these planning and expectations are subject to change. Problems related to financial situation, exclusion from social environment, psychological state, sense of burnout and educational status are among the other problems experienced by caregivers. It has been determined that there are many problems that caregivers experience psychologically, and it is necessary to support caregivers by conducting various interventional studies for these problems. As a result of the researches carried out in the caregivers of the disabled individuals, the existence of negative psychological conditions such as low quality of life, depression and anxiety has been determined and it has been seen that interventional studies are needed in this regard. It has been concluded that yoga has positive effects on other caregivers regarding the problems experienced by caregivers of disabled individuals. This study was planned in accordance with the randomized controlled research design. It will be held between November 2021 and April 2022 with the caregivers of the students registered in the Guidance and Research Centers in Gebze and Darıca Districts of Kocaeli Province. All caregivers between the ages of 18-65 of the students enrolled in the Guidance and Research Centers in Gebze and Darıca Districts in Kocaeli constitute the universe of the research. Using the G Power 3.1.9.4 program, the sample size calculated with a confidence interval of 0.05 and a power of 90% and a large effect size was calculated to be 16 for each group and a total of 32 caregiver studies. It is planned to reach 40 caregivers from each group and 80 caregivers in total, considering the parametric test assumptions and 10% sample loss. Randomization: After filling the pre-test questionnaires with the caregivers who agreed to participate in the research, it will be done by using the SPSS (24.0) statistical package program in the computer environment, taking into account the care burden, quality of life and psychological well-being scale scores. Inclusion Criteria; -Being between the ages of 18- 65, -Caring for a person with special needs for 6 months or more, -Having no physical dysfunction that would prevent doing yoga (COPD, septum deviation, etc.) -Having never done yoga before, -Refused to participate in the study -Speaking Turkish, -The caregiver has internet access, -The caregiver has a computer/tablet with a camera Exclusion criteria; - Having cognitive and musculoskeletal system, neuromuscular and chronic systemic diseases that prevent doing yoga, - Having had a surgical operation in the last 1 month, - Not being willing to participate in the study. Socio-demographic data and web-based yoga initiative were defined as independent variables. Scale total scores and sub-dimension total scores were defined as dependent variables. Socio-demographic Data Collection Form, Caregiver Burden Scale, Multidimensional Quality of Life Scale and Warwick-Edinburgh Mental Well-Being Scale will be applied to caregivers in the intervention and control groups included in the study. Informed consent will be obtained from caregivers participating in the study. The yoga initiative to be applied to the intervention group; Yoga, which is mind-breath-body work; It includes meditation, pranayama (breath work), and asanas (yoga poses). The yoga practice will be applied by the researcher who has a RYT-200 Yoga Alliance yoga instructor certificate over the Zoom application in order to minimize the risk of infection, considering the COVID-19 pandemic period. The content of the yoga practice consists of the following poses: -Tadasana (Mountain pose), -Urdhvahastasana, -Uttanasana, -Ardha Uttanasana, -Plank, -Ashtang Pranam, -Bhujangasana (Mini cobra), -Adho Mukha Svanasana (Downward facing dog), -Vrksasana (Tree Pose), - Utthita Trikonasana (Triangle Pose), -Virabhadrasana I (Warrior I), -Virabhadrasana II (Warrior II), -Virabhadrasana I with Anjali Mudra (Hands Reverse Namaste), -Utkatasana (Chair Pose), -Salabhasana, -Paschimottanasana , -Dandasana, -Salamba Sarvangasana (Shoulder pose), -Ardha Urdhva Dhanurasana (Half Wheel Pose), -Reverse Warrior, -Child's pose, -Ananda Balasana (Happy baby), -Wipers, -Corpse Pose Evaluation of Data: While evaluating the data of the research, descriptive statistics (mean, std. deviation, median, etc.) for numerical variables and frequency distributions for categorical variables will be given. In the study, Kolmogorov Smirnov or Shapiro-Wilk normal distribution test will be used to examine the conformity of the variables to the normal distribution. Demographic data, total scores obtained from the scales in the experimental and control groups will be compared with the chi-square and t test. The difference between the experimental and control groups will be evaluated with an independent two-group t-test. The significance level will be accepted as 0.05. The power and effect size of the study will be calculated by regression analysis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Quality of Life, Psychological Stress
Keywords
yoga, Caregiver burden, Quality of Life, psychological well-being, individuals with special needs

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Technology-Supported Yoga Applied Group
Arm Type
Experimental
Arm Description
The yoga initiative to be applied to the intervention group; Yoga, which is mind-breath-body work; It includes meditation, pranayama (breath work), and asanas (yoga poses). The content of the yoga practice consists of the following poses: -Tadasana (Mountain pose), -Urdhvahastasana, -Uttanasana, -Ardha Uttanasana, -Plank, -Ashtang Pranam, -Bhujangasana (Mini cobra), -Adho Mukha Svanasana (Downward facing dog), -Vrksasana (Tree Pose), - Utthita Trikonasana (Triangle Pose), -Virabhadrasana I (Warrior I), -Virabhadrasana II (Warrior II), -Virabhadrasana I with Anjali Mudra (Hands Reverse Namaste), -Utkatasana (Chair Pose), -Salabhasana, -Paschimottanasana , -Dandasana, -Salamba Sarvangasana (Shoulder pose), -Ardha Urdhva Dhanurasana (Half Wheel Pose), -Reverse Warrior, -Child's pose, -Ananda Balasana (Happy baby), -Wipers, -Corpse Pose
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
No intervention was made in caregivers.
Intervention Type
Other
Intervention Name(s)
Yoga Practice
Intervention Description
In this study, the yoga initiative to be made for the caregivers in the experimental group consists of breathing, meditation and yoga poses.
Intervention Type
Other
Intervention Name(s)
Ongoing caregivers
Intervention Description
Caregivers included in the control group, who did not apply any yoga intervention, will be observed as caregivers.
Primary Outcome Measure Information:
Title
Caregiver Burden Scale
Description
The scoring of the 22-item scale is 1 (never), 2 (rarely), 3 (sometimes) and 4 (often) for each item. The total score of the scale ranges from 22 to 88. A maximum of 88 points can be obtained from the scale. The higher the score on the scale, the higher the burden of care is evaluated in the scale.
Time Frame
at 6 months
Title
Multidimensional Quality of Life Scale (MILQ)
Description
The MILQ questionnaire is a 35-item scale addressing 9 sub-dimensions. The answers in the scale are numbered from 1 to 7. 1 is expressed as "not at all satisfied" and "7" is expressed as "very satisfied". The total score of the scale varies between 35-245. Higher scores represent better functional status.
Time Frame
at 6 months
Title
Warwick-Edinburgh Mental Well-Being Scale
Description
It consists of 14 items, the scale is in 5-point Likert type and a minimum of 14 and a maximum of 70 points can be obtained from the scale. High scores from the scale indicate high mental (psychological) well-being.
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being between the ages of 18- 65, Caring for an individual with special needs, Absence of cognitive and physical dysfunction that would prevent doing yoga, Agreeing to participate in the study and obtaining consent, Having never done yoga before Speaking Turkish, The caregiver has internet access, The caregiver has a computer/tablet/phone with a camera Exclusion Criteria: Having cognitive and musculoskeletal system, neuromuscular and chronic systemic diseases that prevent doing yoga, Having had a surgical operation in the last 1 month, Not being willing to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuğba ÖZDEMİR, PhD
Organizational Affiliation
Maltepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gülendam KARADAĞ, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maltepe University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Yoga on Care Load, Quality of Life, and Psychological Well-Being of Indivıduals With Special Needs

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