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, this randomized controlled trial included 55 chemotherapy patients who were randomly assigned to an intervention group (n = 27) receiving 40-minute weekly laughter yoga sessions for four weeks or to a control group (n = 28) receiving routine care. 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
55

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Nov 2024

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
9 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
8 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

May 18, 2026

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

September 26, 2024

Last Update Submit

May 15, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Edmonton Symptom Assesment Scale (ESAS)

    Bruera et al. (1991) to evaluate nine symptoms commonly seen in cancer patients. These symptoms are pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, feeling good, shortness of breath and other problems. In the other problems section of the scale, 2 additional symptoms seen in patients by researchers (feeling of thirst and discomfort due to catheters and catheters) were added in accordance with literature information. The severity of each symptom is evaluated with numerical numbers from 0 to 10. A score of 0 indicates that there is no symptom, a score of 10 indicates that the symptom is felt very severely, and the severity of the symptom increases from 0 to 10.

    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+)

You may not qualify if:

  • Discontinuation Criteria: (1) withdrawal request, (2) worsening of clinical condition, (3) change in treatment protocol.

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

November 1, 2024

Primary Completion

June 30, 2025

Study Completion

August 15, 2025

Last Updated

May 18, 2026

Record last verified: 2024-10

Locations