NCT07212517

Brief Summary

The aim of this study is to investigate the effect of Benson Relaxation Exercises on sleep quality in hospitalized patients diagnosed with lung cancer. It is planned to be conducted as a randomized controlled trial. Hypotheses of the Study H1: The sleep quality of lung cancer patients who undergo Benson relaxation exercises is statistically significantly better than that of patients who do not undergo such exercises. H2: There is no significant difference in sleep quality between patients who undergo Benson relaxation exercises and those who do not.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

September 30, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

October 8, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

September 30, 2025

Last Update Submit

September 30, 2025

Conditions

Keywords

cancer patientBenson relaxationsleep Quality

Outcome Measures

Primary Outcomes (1)

  • Sleep quality-Pittsburg Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI)

    up to 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

patients will be randomly assigned to groups using this program. Patients included in the study will be numbered according to their order of arrival and assigned to the intervention and control groups according to the order in the randomization listThis study is planned to be conducted on patients diagnosed with lung disease. Patients with additional mental illness, oxygen saturation values below 90, pain scores above 5, and bloody sputum will be excluded from the study.

Behavioral: benson relaxation exercise

control

NO INTERVENTION

Patients will be randomly assigned to groups using this program. Patients included in the study will be numbered according to their order of arrival and assigned to the intervention and control groups according to the order in the randomization listThis study is planned to be conducted on patients diagnosed with lung disease. Patients with additional mental illness, oxygen saturation values below 90, pain scores above 5, and bloody sputum will be excluded from the study.

Interventions

BRT is one of the behavioural intervention techniques developed by Herbert Benson in 1975. BRT is based on the principle of deep breathing and relaxing all the muscles in the body by choosing a word that is meaningful for the individual and focusing on it. This exercise, which has no side effects on patients and can be applied for patients of all age groups, is more widely used because it is a simple and easy-to-learn method compared to other relaxation methods all the muscles in the body by choosing a word that is meaningful for the individual and focusing on it.

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years and over,
  • Have been diagnosed with lung cancer and be receiving inpatient treatment,
  • Be conscious and able to communicate,
  • Agree to participate in breathing exercises during the study,
  • Score above 5 on the PSQI,
  • Sign a written informed consent form.

You may not qualify if:

  • Patients under 18 years of age,
  • Those with additional mental or cognitive disorders,
  • Those with physiological barriers to performing breathing exercises,
  • Those unable to complete the programme during the study period,
  • Those with a PSQI score above 5,
  • Those who violated the study protocol,
  • . Those with an oxygen saturation value below 90,
  • Those scoring above 5 on the Visual Pain Scale,
  • Those who have previously practised yoga or meditation,
  • Patients with haemoptysis,
  • Patients taking any anxiolytic or hypnotic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
experimental and control groups
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: randomized controlled trial single blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Dr. (Psychiatric Nursing)

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 8, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

October 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share