NCT06654869

Brief Summary

Non-pharmacological interventions that promote positive emotional states and coping may play a critical role in care of cancer patients undergoing chemotherapy.This study aimed to evaluate the effects of laughter yoga on symptoms, hope, and life engagement levels in cancer patients undergoing chemotherapy. Conducted between January and June 2025 at the chemotherapy unit of Atatürk University Research Hospital in Türkiye. . Sixty patients were randomized (30 per group). Five were excluded after randomization before baseline assessment because of changes in medical treatment, leaving 55 participants in the per-protocol analysis (intervention n= 27; control n= 28). Symptom severity, hope, and life engagement were measured at baseline and after four weeks using the Edmonton Symptom Assessment Scale (ESAS), Herth Hope Scale (HHS), and Life Engagement Scale (LES). Post-intervention analyses revealed statistically significant improvements in the intervention group compared to the control group. Patients who received laughter yoga reported significantly lower symptom severity on the ESAS (p \< 0.05), along with significantly higher levels of hope and life engagement as measured by the HHS and LES, respectively (p \< 0.05).

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 cancer

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable cancer

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

First Submitted

Initial submission to the registry

September 26, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

September 26, 2024

Last Update Submit

August 24, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Edmonton Symptom Assesment Scale (ESAS)

    The scale, originally developed by Bruera et al. (1991) to assess nine common symptoms in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. For this study, the Turkish version validated by Sadırlı and Ünsar (2009) was utilized, which includes three additional symptoms-changes in skin and nails, mouth sores, and numbness in the hands-resulting in a 12-item scale. Each symptom is rated on a numerical scale from 0 "symptom absent" to 10 "worst possible severity". In the Turkish validation study, Cronbach's alpha coefficients were reported as 0.83 for the pre-test and 0.76 for the post-test. In the present study, the Cronbach's alpha coefficients for the scale were calculated as 0.71 and 0.72 for the pre-test and post-test, respectively.

    4 weeks

  • Life Engagement Scale

    The Life Engagement scale, developed by Scheier et al. (2006) to assess individuals' life goals and whose Turkish validity and reliability were determined by Akın et al., is a measurement tool consisting of 6 items and a single dimension (life engagement). The scale has a 5-point scale ("1" I completely disagree, "5" I completely agree). Items 1, 3 and 5 are reverse coded in the scale. Increasing scores indicate a high level of life engagement.

    4 weeks

  • Herth Hope Scale

    The Herth Hope Scale was developed by Kaye Herth. The scale consists of 30 items. Each item has four options: "Never " "Rarely appropriate," "Sometimes" and "Always " . The corresponding scores are 0, 1, 2, and 3, respectively. The respondent is asked to mark a single option for each item. The scale consists of 3 sub-dimensions. These are "Future," "Positive Readiness and Expectation," and "Relationships Between Oneself and Those Around Oneself." The "Future" sub-dimension measures the cognitive-temporal dimension of hope, the "Positive Readiness and Expectation" sub-dimension measures the emotional-behavioral dimension of hope, and the "Relationships Between Oneself and Those Around Oneself" sub-dimension measures the dimension of hope related to relationships and the conditions in which it exists. The total hope score varies between 0-90, and the total score of each subscale varies between 0-30. High scores, It shows that hope is high.

    4 weeks

Study Arms (2)

Arm 2

NO INTERVENTION

Arm 1

EXPERIMENTAL

laughter yoga

Behavioral: lauhgter yoga

Interventions

lauhgter yogaBEHAVIORAL

include laughter yoga effects on cancer patients' symptom management

Arm 1

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Üniversitesi

Erzurum, Yakutiye, 25080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Allocation concealment was ensured by an independent external researcher who held the randomization list and was not involved in patient recruitment or intervention thus ensuring that the researchers remained blinded to the group assignments during the initial evaluation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 23, 2024

Study Start

January 30, 2025

Primary Completion

June 30, 2025

Study Completion

August 15, 2025

Last Updated

August 26, 2026

Record last verified: 2026-08

Locations