NCT05985824

Brief Summary

This research is a randomized controlled experimental study to determine the effect of pranayama breathing exercise applied to patients with lung cancer on quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable lung-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

Study Start

First participant enrolled

January 6, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2024

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

August 1, 2023

Last Update Submit

May 22, 2025

Conditions

Keywords

Lung cancerPranayamaQuality of LifeNursing

Outcome Measures

Primary Outcomes (1)

  • Quality of life of lung cancer patients

    European Organization for Cancer Research and Treatment Quality of Life Scale :measure lung cancer patients before and four weeks aftter. European Organization for Cancer Research and Treatment Quality of Life Scale: scale consists of 3 sub-titles: general well-being, functional area and symptom control. While the maximum score that patients will get from these three sub-headings is 100, the minimum score is 0. The first 28 questions are questions related to the functional area and symptom control subheadings, and low scores on these questions mean high quality of life, and high scores mean low quality of life. The last two questions belong to the sub-heading of general well-being, and a low score on these questions indicates a low quality of life, and a high score indicates a high quality of life.

    four weeks

Study Arms (2)

Applications to the Intervention Group

EXPERIMENTAL

Patients with lung cancer admitted to the outpatient chemotherapy unit will be given pranayama breathing exercises every day for 4 weeks, covering 15-20 minutes. In patient education, the pranayama breathing exercise will be applied face-to-face by the researcher on the first day of chemotherapy treatment, before drug treatment. The application steps will be repeated until the patient learns, both by explaining and showing the patient, and if there are points that the patient cannot do, they will be corrected. When the patients are observed to perform the application fully and the chemotherapy treatments are finished, they will be asked to do the pranayama breathing exercise every day for 4 weeks, and with the same researcher 3 days a week (Monday, Wednesday, Saturday) with a smart phone whatsapp video call, the effectiveness and continuity of the application will be ensured and the patients will be monitored.

Procedure: Pranayama breathing exercise

Applications to the Control Group

NO INTERVENTION

A pre-test will be applied to lung cancer patients in the control group who applied to the day chemotherapy unit. After the application of the personal information form and the quality of life scale, no breathing exercises will be performed. Individuals will continue their daily lives. After 4 weeks, the quality of life scale will be administered again. After the implementation of the quality of life scale, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions.(The study will begin before the patients in both the experimental and control groups receive chemotherapy, which is their routine treatment).

Interventions

Pranayama is an important step in yoga, way of life, and is translated as "the science of breathing, breath control, willful breathing". This alternating breathing-out action also balances the sympathetic and parasympathetic nervous systems, giving the person a state of calm, providing relaxation and positively affecting fatigue. Application steps; Right hand Nasika mudra is performed. Nasika mudra is the mudra where the second and third fingers of the right hand are folded into the palm and the other fingers are exposed. Then the right nostril is closed with the first finger of the right hand. Start by breathing through the left nostril. Then the left nostril is closed with the fourth finger and the breath is held. While the left nostril is closed, the right nostril is opened and inhaled. Breathe again through

Applications to the Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Over 18 years old,
  • Lung Cancer Stage III and IV,
  • Being literate,
  • Having sufficient communication skills,
  • Does not have any ailment that will reduce the ability to comprehend and understand,
  • Agreeing to participate in the research,
  • Knowing the diagnosis,
  • Receiving chemotherapy treatment,
  • ECOG performance score ≤ 2,
  • Not using opioids or sedating drugs,
  • Patients who can use smart phones themselves or their relatives will be included in the study

You may not qualify if:

  • Lung Cancer I., II., stage,
  • Receiving radiotherapy,
  • Having a history of Brain Metastasis,
  • Using integrated health practices in the treatment process,
  • Those who exercise regularly
  • For patients over 65 years of age, patients with a score below 24 on the mini mental test were not included in the study.
  • Research Termination Criteria
  • Intervention Group
  • Developing additional health problems,
  • Unwilling to continue the practice of pranayama breathing exercise,
  • Those who lost their lives during the research process,
  • Those who do not practice pranayama breathing exercise as recommended or cannot do it effectively,
  • The study will be terminated with patients who want to withdraw from the study.
  • Control Group
  • Developing additional health problems,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Talas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients with primary diagnosis of lung cancer who met the inclusion criteria of the study and volunteered to participate in the study will constitute the sample of the study. 35 per group for the sample of the study. A total of 70 people will be sampled.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 14, 2023

Study Start

January 6, 2023

Primary Completion

January 27, 2024

Study Completion

January 27, 2024

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

We plan to share it after it is ready for publication.

Locations