NCT05218291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

January 20, 2022

Last Update Submit

June 8, 2022

Conditions

Keywords

yogaCaregiver burdenQuality of Lifepsychological well-beingindividuals with special needs

Outcome Measures

Primary Outcomes (3)

  • 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.

    at 6 months

  • 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.

    at 6 months

  • 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.

    at 6 months

Study Arms (2)

Technology-Supported Yoga Applied Group

EXPERIMENTAL

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

Other: Yoga Practice

Control Group

ACTIVE COMPARATOR

No intervention was made in caregivers.

Other: Ongoing caregivers

Interventions

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

Technology-Supported Yoga Applied Group

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

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver BurdenStress, PsychologicalPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Tuğba ÖZDEMİR, PhD

    Maltepe University

    PRINCIPAL INVESTIGATOR
  • Gülendam KARADAĞ, PhD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 1, 2022

Study Start

November 15, 2021

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations