NCT07877012

Brief Summary

This study aimed to evaluate the effects of the 4-7-8 breathing technique performed before colonoscopy on patients' anxiety, pain, and embarrassment. Colonoscopy is a procedure used to examine the inside of the large intestine and may cause anxiety, discomfort, and embarrassment in some patients. In this randomized controlled study, 104 patients undergoing colonoscopy were assigned to either an intervention group or a control group. Patients in the intervention group performed the 4-7-8 breathing technique before colonoscopy, while patients in the control group received usual care. Anxiety, pain, and embarrassment were assessed to compare outcomes between the two groups. This study aimed to evaluate the effects of the 4-7-8 breathing technique performed before colonoscopy on patients' anxiety levels, pain intensity, feelings of embarrassment, and physiological parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable anxiety

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

November 30, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

6 months

First QC Date

October 9, 2026

Last Update Submit

October 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anxiety Level (State Anxiety Inventory Score)

    Anxiety was assessed using the State-Trait Anxiety Inventory-State subscale (STAI-S) at baseline (T0), immediately before sedation and colonoscopy (T1), and after the procedure when the patient had fully recovered (T2). Scores were compared between the intervention and control groups.

    Baseline (T0), immediately before sedation and colonoscopy (T1), and after the procedure following full cognitive recovery (T2).

Study Arms (2)

4-7-8 Breathing Exercise Group

EXPERIMENTAL
Behavioral: 4-7-8 Breathing Technique

Control group

NO INTERVENTION

Interventions

Participants received individualized instruction on the 4-7-8 breathing technique from the principal investigator approximately 30 minutes before colonoscopy. The technique involved inhaling through the nose for 4 seconds, holding the breath for 7 seconds, and exhaling slowly through the mouth for 8 seconds. Participants completed four breathing cycles per set and two sets in total, with an intervention duration of approximately 8-10 minutes. After the exercise, participants rested for 10 minutes in a quiet pre-procedural room before the pre-procedural assessments and sedatio

4-7-8 Breathing Exercise Group

Eligibility Criteria

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

You may not qualify if:

  • Patients were excluded if they were under 18 years of age, had hearing or speech impairments that would prevent understanding of the breathing technique instructions, regularly used anxiolytics or sedatives, or exhibited abnormal vital sign fluctuations requiring acute medical intervention during or after the procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erhan Ergin Kliniği

Manisa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2026

First Posted

October 15, 2026

Study Start

November 30, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

October 15, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations