NCT06613061

Brief Summary

Breathing exercises are one of the most useful techniques to reduce stress and anxiety. The aim of this study is to determine the effects of breathing exercises on pain, anxiety and fatigue in patients receiving brachytherapy treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

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

August 19, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

September 23, 2024

Last Update Submit

May 11, 2025

Conditions

Keywords

radiothreapy

Outcome Measures

Primary Outcomes (3)

  • Numerical pain scale

    Numerical pain scale: The numerical pain scale is a one-dimensional scale and the expressions "no pain" and "unbearable pain" are located at both ends of the figure. There are values between 0-10 on the scale at equal intervals and the patient marks them according to the level of pain.The scale scores between 0-10. The high total score indicates the high pain level experienced by the person.

    Two week

  • Beck Anxiety Inventory

    The Beck Anxiety Inventory (BAI) is a Likert-type assessment scale consisting of 21 items and scored between 0-3, designed to measure the frequency of anxiety symptoms experienced by the individual. Individuals rate each item by giving a score between 0-3 to determine how uncomfortable they have felt "over the past week, including the day of the application". The scale scores between 0-63. The high total score indicates the high level of anxiety experienced by the person

    Two week

  • Piper Fatigue Scale

    Piper Fatigue Scale (PFS): The PFS consists of 22 questions and evaluates fatigue perception subjectively. It has four sub-dimensions: the behavior/severity sub-dimension, which evaluates the effect and severity of fatigue on daily life activities; the affective sub-dimension, which covers the emotional meaning attributed to fatigue; the sensory sub-dimension, which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/spiritual sub-dimension, which reflects the degree to which fatigue affects cognitive functions and mood. The total score of the scale varies between 0 and 10. A score of 0 indicates no fatigue, 1-3 indicates mild fatigue, 4-6 indicates moderate fatigue, and 7-10 indicates severe fatigue.

    Two week

Study Arms (2)

Experimental (breathing exercise)

EXPERIMENTAL

The researcher has a breathing exercise certificate. In our study, the breathing exercise application consists of three stages: box breathing, sigh breathing and diaphragm breathing. Patients will be asked to continue the breathing exercise application for 2 weeks and will be reminded to do the breathing exercises. Box and sigh breathing will be done 3 times a day (morning, noon and evening) every day for 2 weeks. Diaphragm breathing exercise will be applied for 2 minutes in the first week and 4 minutes in the second week.

Other: Breathing exercise

Control

NO INTERVENTION

The control group will receive standard care. No intervention will be applied to these patients during the follow-up period, only data collection forms will be applied. Data collection forms will be collected in the same time period as the intervention group.

Interventions

The researcher has a breathing exercise certificate. In our study, the breathing exercise application consists of three stages: box breathing, sigh breathing and diaphragm breathing. Patients will be asked to continue the breathing exercise application for 2 weeks and will be reminded to do the breathing exercises. Box and sigh breathing will be done 3 times a day (morning, noon and evening) every day for 2 weeks. Diaphragm breathing exercise will be applied for 2 minutes in the first week and 4 minutes in the second week.

Experimental (breathing exercise)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old
  • Being willing to participate in the study
  • Being able to speak and understand Turkish

You may not qualify if:

  • Having a malignancy related to the respiratory system (bronchus or lung)
  • Having chest pain
  • Having done box breathing and diaphragm breathing exercises/receiving training before
  • Having cognitive dysfunction
  • Not giving consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Amasya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 25, 2024

Study Start

August 19, 2024

Primary Completion

May 10, 2025

Study Completion

May 11, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations