Laughter Yoga Effect on Cancer Patients' Physiopsychological Symptoms

NCT ID: NCT06654869

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-04-30

Brief Summary

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The universe of this study will consist of cancer patients and their relatives who are hospitalized in the medical oncology clinic of Atatürk University Research and Practice Hospital between Oct 2024 and Feb 2024. The researcher will stratify the patients in the control and intervention groups according to age and the type of treatment they receive in order to ensure homogeneity. Accordingly, the patient in each stratum will be selected from one of the labels prepared in a bag with the words "experimental" and "control" written on it and the patient will be included in the group written on the label. The patients in the control and intervention groups will not know which group they are in, but only the researcher will know who is in which group. In this way, blinding will be ensured and the study will be completed as single-blind.

Detailed Description

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Sample Size Calculation:

The minimum number of people to be included in the sample was calculated by performing a power analysis. Using the "G.Power-3.1.7" program, the sample size was calculated with a test power of 0.80. As a result of the power analysis, it was determined that a total of 60 patients should be included in the control and intervention groups at α=0.05 level and 80% power. The patients to be included in the study will be randomized and assigned to the intervention (n=30) and control (n=30) groups. Volunteer acceptance for the study will begin after the acceptance of the study within the created work packages.

Data collection tools:

The data of the study will be collected in the experimental and control groups using the "Personal Information Form", "Edmonton Symptom Assesment Scale", "Herth Hope Scale" and "Life Engagement Scale".

Criteria for volunteers to be included in the study:

1. Being 18 years of age or older
2. Being diagnosed with cancer and having knowledge about the disease
3. Not having a physical illness or cognitive disability that would prevent understanding the scales used for data collection and the education provided, and not having a psychiatric illness diagnosis
4. Being literate
5. Being open to communication and collaboration

Conditions

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Cancer Nurse's Role Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 2

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 1

laughter yoga

Group Type EXPERIMENTAL

lauhgter yoga

Intervention Type BEHAVIORAL

include laughter yoga effects on cancer patients' symptom management

Interventions

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lauhgter yoga

include laughter yoga effects on cancer patients' symptom management

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Being 18 years of age or older
2. Being diagnosed with cancer and having knowledge about the disease
3. Not having a physical illness or cognitive disability that would prevent understanding the scales used for data collection and the education provided, and not having a psychiatric illness diagnosis
4. Being literate
5. Being open to communication and collaboration

Exclusion Criteria

1. Being under 18 years of age
2. Not having information about the disease
3. Having a physical illness or cognitive disability that prevents understanding the scales used for data collection and the education given, and being diagnosed with a psychiatric disease
4. Being illiterate
5. Not being open to communication and cooperation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Yasemin Ciraci Yasar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yasemin ÇIRACI YAŞAR, Ph.D

Role: CONTACT

00904422312172

Yasemin ÇIRACI YAŞAR, Ph.D

Role: CONTACT

00904422312172

Other Identifiers

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ATATURKU-NRS-YCY-02

Identifier Type: -

Identifier Source: org_study_id

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