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Caregiver BurdenYogaNCT05218291

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

A study testing Yoga Practice and Ongoing caregivers in people with Caregiver Burden and Quality of Life, run by Maltepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Yoga Practice and Ongoing caregivers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Nov 2021to 1 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Maltepe University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: the Effect of Technology Applıed Yoga on Care Load, Qualıty of Lıfe, and Psychologıcal Well-Beıng of Indıvıduals Wıth Specıal Needs

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.

Read the 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

Being tested
Yoga Practice, Ongoing caregivers
Keywords
yoga, Caregiver burden, Quality of Life, psychological well-being, individuals with special needs
Medical subject headings
Caregiver Burden, Stress, Psychological, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga PracticeOther

    In this study, the yoga initiative to be made for the caregivers in the experimental group consists of breathing, meditation and yoga poses.

  • Ongoing caregiversOther

    Caregivers included in the control group, who did not apply any yoga intervention, will be observed as caregivers.

Study groups in NCT05218291
Study groupRoleWhat they receive
Technology-Supported Yoga Applied GroupExperimentalThe 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
Receives: Other: Yoga Practice
Control GroupActive comparatorNo intervention was made in caregivers.
Receives: Other: Ongoing caregivers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 6 months

  2. 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.

    Measured: at 6 months

  3. 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.

    Measured: at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start15 Nov 2021
  3. Primary completion1 Apr 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218291
Sponsor's protocol ID
55
Acronym
Yoga
Status last verified
Jun 2022
First submitted
20 Jan 2022
Last updated
9 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Yoga Practice and Ongoing caregivers in people with Caregiver Burden and Quality of Life, run by Maltepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver Burden Scale (time frame: at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.

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