NCT07667959

Brief Summary

This is a study conducted to evaluate the effect of the Benson relaxation exercise on resolving sleep problems in cancer patients. It uses a randomized controlled pre-test/post-test design.

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 cancer

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 27, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 17, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

cancersleep qualityRelaxation exercise

Outcome Measures

Primary Outcomes (1)

  • Sleep quality

    Pittsburgh Sleep Quality Index: The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality and sleep disturbances over the previous month. It consists of 19 self-rated items that generate seven component scores and a global score, with higher scores indicating poorer sleep quality.

    6 months

Study Arms (2)

Benson relaxation exercise

EXPERIMENTAL

Benson Relaxation Exercises were developed by Dr. Herbert Benson. It is a non-pharmacological, non-invasive, and easy-to-learn method that relaxes all muscles.

Behavioral: Benson relaxation exercise

Sleep hygiene

PLACEBO COMPARATOR

A sleep hygiene booklet has been created and provides information about sleep hygiene.

Behavioral: Sleep hygiene

Interventions

Relaxation exercises, developed by Dr. Herbert Benson, are a non-pharmacological, non-invasive, and simple method of learning that relaxes all muscles. It is emphasized as being the most suitable method in terms of ease of application and learning compared to other relaxation exercises. This method is used as an effective and reliable way to solve various problems such as controlling stress, relieving pain, improving mood disorders, and enhancing sleep quality.

Benson relaxation exercise
Sleep hygieneBEHAVIORAL

A booklet on sleep hygiene was created, and training was provided.

Sleep hygiene

Eligibility Criteria

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

You may qualify if:

  • Over 18 years old
  • Given cancer disease
  • Don't have any communication problems

You may not qualify if:

  • Having an illness other than a cancer diagnosis
  • Using any narcotic agent that causes sedation
  • Using any farmacologic agent for sleep problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadi Konuk Hospital

Istanbul, 34450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Professor

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 25, 2026

Study Start

September 27, 2025

Primary Completion

November 27, 2025

Study Completion

February 28, 2026

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations