NCT06460259

Brief Summary

Surgical treatment is performed with the aim of reducing, halting the progression of, or treating certain pathological conditions in the human body by removing some tissue or organs from the body. Wedge resection is considered an effective method for the treatment of lung cancer. The wedge resection method is utilized in both malignant and non-malignant pulmonary pathologies (such as bronchiectasis, aspergilloma, non-tuberculous mycobacteria, tuberculosis, fungal infections, inflammatory pseudotumors, hydatid cyst, and benign masses). Following surgical procedures such as Video-Assisted Thorascopic Surgery (VATS) and wedge resection, side effects and complications such as atelectasis, pneumonia, acute respiratory distress syndrome, prolonged air leakage, chylothorax, sepsis, pneumothorax, pulmonary embolism, empyema, bronchopleural fistula, pain, anxiety, dyspnea, fatigue, and insomnia can occur. Non-pharmacological methods are observed to increase comfort and control in patients, thereby enhancing their quality of life. Non-pharmacological interventions such as music therapy, hot or cold therapy, hypnosis, aromatherapy, massage, progressive relaxation exercises, deep breathing exercises, pursed lip breathing, yoga, and meditation can be employed in the management of postoperative symptoms such as pain, anxiety, dyspnea, insomnia, and fatigue. Studies involving breathing exercises have shown that they reduce anxiety and pain scores after exercise. Alternate nostril breathing, a yoga practice, is considered one of the best breathing exercises for health and fitness. It has positive effects on dyspnea, anxiety, stress, and sleep disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

1.6 years

First QC Date

June 5, 2024

Last Update Submit

September 1, 2025

Conditions

Keywords

Breathing exercisesInsomniaPainAnxiety

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale (VAS) - Pain Scale

    A 10 cm ruler has been designed with painlessness on one side and the most severe pain possible on the other side. This ruler is known as the Visual Analog Scale (VAS) for visual comparison. In the evaluation of the scale, "0" indicates no pain, "1-3" indicates mild pain, "4-6" indicates moderate pain, and "7-10" indicates severe pain levels.

    First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.

  • Visual Analog Scale (VAS) - Dyspnea Scale

    The Visual Analog Scale (VAS) is applied by marking with a pencil on a horizontal or vertical line of one hundred millimeters. The 0 mm point of the line indicates no dyspnea, while the 100 mm point indicates the most severe dyspnea possible. The patient marks the severity of their current respiratory distress on the scale by using these two degrees as criteria.

    First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.

  • State-Trait Anxiety Inventory

    he development of the State-Trait Anxiety Inventory was conducted by Spielberger and his colleagues (1970), and it consists of two subscales: state anxiety and trait anxiety, each comprising 20 items. The scores obtained from both scales theoretically range between 20 and 80. A large score indicates a high level of anxiety, a small score indicates a low level of anxiety.

    First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.

Secondary Outcomes (1)

  • Richard Campbell Sleep Scale

    First measurement on the day before surgery, second measurement on the first day after surgery, third measurement on the second day after surgery.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patients undergoing VATS or wedge resection procedures will be informed and their consent will be obtained prior to the procedure. Individuals who consent and meet the inclusion criteria will fill out a personal information form and then be randomly assigned to groups using simple randomization method. Breathing exercises will be taught individually to participants in the experimental group by the researcher. In the experimental group, breathing exercises will be performed approximately 10 minutes, four times a day, starting from the first day after oral intake.

Behavioral: Breathing Exercise

Control Group

NO INTERVENTION

No intervention other than routine nursing care will be performed.

Interventions

He individual will be seated in a quiet environment in a semi-fowler or fowler position with their feet pointing forward. Then, they will be asked to join their hands on their abdomen and breathe normally while focusing on their breath. They will ensure their shoulders are relaxed, their body is loose, and they will inhale and exhale slowly and deeply through the nose without rushing.Next, while sitting upright with relaxed muscles, they will close their eyes, block their right nostril with their thumb or ring finger, inhale as much air as possible through the left nostril, and hold their breath. Then, they will block the left nostril with their ring finger or thumb and exhale slowly through the right nostril. The same process will be repeated for the left nostril. They will continue this process for approximately 2 minutes.

Experimental Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having undergone VATS or wedge resection surgery,
  • Having orientation to place and time,
  • Being communicative,
  • Having no visual or hearing impairment.

You may not qualify if:

  • Having a mental health issue that would hinder communication,
  • Having any nasal pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersPainAnxiety Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Fatma Gündoğdu, PhD

    KTO Karatay University

    PRINCIPAL INVESTIGATOR
  • Hasibe Okutan, PhD

    Konya City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor, PhD

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 14, 2024

Study Start

August 1, 2023

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The researcher at Konya City Hospital will collect the data.

Locations