NCT06232681

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 13, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

January 22, 2024

Last Update Submit

January 31, 2024

Conditions

Keywords

progressive relaxation exerciseburdencaregiverthe meaning of life

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 day

  • 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.

    30 day

Study Arms (2)

Progressive relaxation exercise application

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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

Progressive relaxation exercise application

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, Yunusemre, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Funda AKTÜRK

    Celal Bayar University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kıvan ÇEVİK KAYA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Celal Bayar University

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

July 13, 2023

Primary Completion

April 19, 2024

Study Completion

April 30, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

The data will be given if it's necessary and if it is not problem for ethical office.

Locations