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RecruitingNCT06232681Updated Feb 1, 2024

The Effect of Progressive Relaxation Exercises Applied to Caregivers on Caregiving Burden and Meaning of Life

An interventional study of Progressive relaxation exercise in Hemiplegia, sponsored by kıvan çevik kaya. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-01.

Sponsored by kıvan çevik kaya · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Jul 2023, registered Jan 2024).
  • Started Jul 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This randomised controlled experimental type study will be conducted with family members who care for the relatives of hemiplegic patients who are hospitalised in Manisa Merkezefendi and Turgutlu State Hospital Physical Therapy Services.

Read the detailed description

The population of the study will consist of the caregivers of hemiplegic patients receiving treatment in the clinic on the specified dates in Turgutlu State Hospital and Manisa Merkezefendi State Hospital Physical Therapy Service. The sample will consist of individuals who meet the inclusion criteria. Individuals in Turgutlu State Hospital will constitute the intervention group of the study and individuals in Manisa Merkezefendi State Hospital will constitute the control group of the study. The aim of this study was to determine the effect of progressive relaxation exercises applied to family members caring for hemiplegic patients on caregiving burden and meaning of life. In the intervention group, those who agree to participate in the study will be asked to fill in the Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. Relaxation exercises will be explained and demonstrated by the researcher (Funda AKTÜRK) once a day for 1 month starting from the hospitalisation to the clinic and will be played on the computer. You will be asked to perform these exercises after listening to the video (CD). Relaxation exercises are exercises based on stretching and relaxing your muscles. Before the application, in the middle of the application (15th day) and at the end of the application, all forms except the introduction form will be filled in again. In the Control Group, those who agree to participate in the study will be asked to fill in the;Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. The control group will be asked to fill in the forms at the same time as the intervention group without any intervention. If requested, progressive relaxation exercises will be applied to the control group after the end of the study

02

Conditions studied

  • Hemiplegia

Keywords

  • progressive relaxation exercise
  • burden
  • caregiver
  • the meaning of life
03

In context

Hemiplegia

374 studies on the registry are indexed under Hemiplegia; 83 are open to participants now.

This study's planned enrollment of 60 is above the median of 34 across 310 interventional studies indexed under Hemiplegia.

Browse Hemiplegia studies →

Lead sponsor

This is the only study on the registry with kıvan çevik kaya as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Family members who have no communication problems,
  • Who are 18 years of age or older,
  • Whose patient will be hospitalised in the clinic for at least one month,
  • Who agree to participate in the study will be recruited.

Exclusion criteria

Exclusion Criteria:

  • Individuals who have communication problems,
  • The caregiver is not a family member,
  • are 18 years of age or younger,
  • The patient stays in the clinic for less than one month,
  • Has previously received progressive relaxation training, and who do not agree to participate in the study will be included.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Progressive relaxation exercise application

    Progressive relaxation exercise practice Those who agree to participate in the study will be asked to fill in the Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. Relaxation exercises will be explained and demonstrated by the researcher (Funda AKTÜRK) once a day for 1 month starting from the hospitalisation to the clinic and will be played on the computer. You will be asked to perform these exercises after listening to the video (CD). Relaxation exercises are exercises based on stretching and relaxing your muscles. Before the application, in the middle of the application (15th day) and at the end of the application, all forms except the introduction form will be filled in again.

    Behavioral: Progressive relaxation exercise

  • No intervention
    Control group

    The participants in the control group also filled in the data collection tools without undergoing any intervention.

Interventions

  • BehavioralProgressive relaxation exercise

    The intervention group will take one month progressive relaxation exercise starting from the hospitalisation to the clinic

06

What researchers measure

Primary outcomes

  1. Care burden

    Caregiving Burden Scale was used. The scale has a Likert-type evaluation ranging from 0 to 4 in the form of never, rarely, sometimes, frequently, often, or almost always. A minimum score of 0 and a maximum score of 88 can be obtained from the scale. The items in the scale are generally related to the social and emotional domain, and a high scale score indicates that the distress experienced is high.

    Time frame: 30 day

  2. The meaning and purpose of life

    Meaning and Purpose of Life Scale was used. The Life's Meaning and Purpose Scale, which is prepared in Likert style and answered by marking one of the options of strongly agree, agree, undecided, disagree and strongly disagree according to frequency, consists of a total of (17) items including (11) positive and (6) negative statements. The options ticked for positive statements are evaluated by scoring as strongly agree (5), agree (4), undecided (3), disagree (2) and strongly disagree (1) respectively, while the options ticked for negative statements are evaluated by scoring in reverse order as strongly agree (1), agree (2), undecided (3), disagree (4) and strongly disagree (5). The lowest score that can be obtained from the scale is (17x1=17) and the highest score is (17x5=85). A high score indicates a high level of meaning in individuals' lives, while a low score indicates a low level of meaning.

    Time frame: 30 day

07

Study locations

1 of 1 sites recruiting
  • Manisa Celal Bayar University
    Manisa, Yunusemre, Turkey
    • Kıvan ÇEVİK KAYA · Contact
    • Funda AKTÜRK · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — The data will be given if it's necessary and if it is not problem for ethical office.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06232681
Lead sponsor
kıvan çevik kaya
Responsible party
kıvan çevik kaya (Celal Bayar University, Celal Bayar University) — Sponsor-investigator
First posted
Jan 31, 2024
Start date
Jul 13, 2023
Primary completion
Apr 19, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Feb 1, 2024

Study contacts

Kıvan ÇEVİK KAYA
Contact
kivancevikk@gmail.com
0 (236) 233 0904
Funda AKTÜRK
principal investigator · Celal Bayar University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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