NCT07164118

Brief Summary

This study will be conducted to evaluate the therapeutic effects of pranayama breathing technique and deep breathing exercises on pain and anxiety after abdominal surgery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 15, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

August 28, 2025

Last Update Submit

September 7, 2025

Conditions

Keywords

abdominal surgerydeep breathing exercisepranamayapainanxiety

Outcome Measures

Primary Outcomes (2)

  • Spielberger State-Trait Anxiety Inventory:

    Spielberger State-Trait Anxiety Inventory: First developed by Spielberger and his colleagues in 1970, it was adapted into Turkish by Öner and Le Compte (1982), and its validity and reliability studies were conducted. This inventory consists of two subsections, each containing 20 items: State Anxiety (STAI-I) and Trait Anxiety (STAI-II). In the state anxiety section, participants select one of the following options: "not at all," "a little," "a lot," or "completely." In the trait anxiety section, participants respond with the following options: "almost never," "sometimes," "most of the time." The total score on the scale ranges from 20 to 80; higher scores indicate higher anxiety levels. In the study conducted by Günaydın and Oflaz (1998), anxiety scores were classified according to their levels and defined as 20-39 as "mild", 40-59 as "moderate", 60-79 as "high" and over 80 points as "panic level anxiety".

    5 months

  • Visual Analog Scale (VAS)

    Visual Analog Scale (VAS) The Visual Analog Scale (VAS) was designed in 1983 by Price and colleagues to assess pain intensity. This measurement tool consists of a 10-cm-long straight line with the words "no pain" at one end and "unbearable pain" at the other. The patient is asked to mark a point on the line corresponding to the intensity of the pain they are experiencing; this point is scored in centimeters from the beginning. The score is categorized as no pain for 0, mild for 1-4, moderate for 5-6, severe for 7-8, and extreme pain for 10.

    5 months

Study Arms (3)

Control Group

NO INTERVENTION

Patients will not be taught breathing exercises. Pain will be assessed with the VAS at the 6th, 12th, and 24th postoperative hours, and anxiety will be assessed with the STAI-II on the preoperative morning and before discharge.

Pranayama Breathing Group

EXPERIMENTAL

Pranayama breathing techniques will be taught before surgery. Starting 4 hours after surgery, 8-10 minutes of breathing exercises will be repeated every 2 hours. Pain will be measured before and after the exercises and at 6, 12, and 24 hours postoperatively. Anxiety will be measured with the STAI-II on the morning of the preoperative period and before discharge.

Behavioral: Pranayama Breathing Exercise

Deep Breathing Group

EXPERIMENTAL

Deep breathing exercises will be taught before surgery. Six repetitions will be performed every two hours, starting four hours after surgery. Pain will be assessed with a VAS before and after the exercise and at 6, 12, and 24 hours. Anxiety will be measured with the STAI-II on the morning of the preoperative period and before discharge.

Behavioral: Deep Breathing Exercise

Interventions

Pranayama breathing technique consisting of 6 cycles, demonstrated by the researcher before the operation, supported by the brochure, and lasting 8-10 minutes every 2 hours from the 4th post-operative hour.

Pranayama Breathing Group

Deep breathing exercise, demonstrated one-on-one before surgery and supported by a guide, applied 6 times every 2 hours from the 4th post-operative hour onwards.

Deep Breathing Group

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-65,
  • Having undergone elective abdominal surgery,
  • Having no communication difficulties,
  • Having no cognitive problems,
  • Having no psychiatric illness,
  • Having not previously practiced breathing exercises,
  • Agreeing to participate in the study,
  • Having an American Society of Anesthesiology (ASA) rating of I, II, or III will be included in the sample group.

You may not qualify if:

  • Patients who developed complications such as bleeding, anastomotic leakage, atelectasis, deep vein thrombosis, or pulmonary embolism in the postoperative period; who wished to withdraw from the study at any stage; or who required intensive care in the postoperative period will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afsin State Hospital

Kahramanmaraş, Afşin, 46500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Before the surgery, patients in the pranayama intervention group will be taught the Pranayama breathing technique. Individuals in the deep breathing exercise intervention group will be taught deep breathing exercises by the researcher before the surgical intervention. No application will be made to the control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are 3 groups: pranamaya group, deep breathing exercise group and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr lecturer

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 9, 2025

Study Start

August 15, 2025

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations