NCT05492929

Brief Summary

Aim: This study aims to determine the effects of the deep breathing exercise and the 4-7-8 breathing technique applied to patients after bariatric surgery on their anxiety and quality of life. Materials and Methods: The study was conducted between January and June 2022 at Ankara Lokman Hekim Akay Hospital Endocrinology and Metabolic Diseases Clinic. The research was carried out using the pre-test post-test randomized controlled experimental research design with a control group. A total of 90 patients (30 patients in the deep breathing group, 30 patients in the 4-7-8 breathing group, and 30 patients in the control group) who met the research inclusion criteria were included in the study. While routine care was applied to the control group, 1 group was given deep breathing training, and the other group was given 4-7-8 breathing training. Personal Information Form, the Obesity-Specific Quality of Life Questionnaire, Status, and the State-Trait Anxiety Inventory were used for data collection. In the evaluation of the data, number, percentage, mean, standard deviation, Kolmogorov Smirnov test, chi- square, dependent samples t-test, ANOVA, Tukey's test, Pearson Correlation analysis, and Cronbach's alpha Reliability Coefficient were used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

January 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 4, 2022

Last Update Submit

August 8, 2022

Conditions

Keywords

4-7-8 breathing techniqueanxietybariatric surgerydeep breathing exercisequality of life

Outcome Measures

Primary Outcomes (2)

  • State and Trait Anxiety Inventory

    The state anxiety scale requires the person to answer at a certain moment and under certain conditions, while the trait anxiety scale requires the person to answer according to how he or she usually feels. This scale, which is a self-evaluation scale, consists of state anxiety and trait anxiety sections. It consists of a total of 40 questions, 20-20 in both. This scale is likert type and is graded as 'not at all-somewhat-very-completely'. The points that can be obtained from this inventory are minimum 20 and maximum 80 points. The scores obtained from the scale are interpreted as increasing the level of anxiety as it approaches 80, and the low level of anxiety as it approaches 20. It is interpreted in the same way when sorting by percentile.

    Change from State and Trait Anxiety Inventory at 24 hours

  • Obese-Specific Quality of Life Scale

    This scale is a 17-item Likert-type scale scored between 0-6. According to the numerical increase order, it is expressed as 'Not at all, Hardly at all, Little, Moderate, Quite, A lot, Extremely'. The scale has no sub-dimensions. The scores obtained from all items of the scale are added together and 17 is subtracted from the obtained score. This score is divided by 102 and multiplied by 100. It is interpreted as the higher the score, the higher the quality of life, and the lower the score, the lower the quality of life.

    Change from Quality of Life at 24 hours

Study Arms (3)

The deep breathing group

EXPERIMENTAL

The deep breathing group was administered the nightly state and trait anxiety scale and SAAQ before the operation, and then they were informed about the deep breathing exercise. Between the 1st and 6th hours of the postoperative period, deep breathing exercise was performed, with 10 breaths per hour. At the end of the 6th hour, the state anxiety scale and SSWS were administered.

Other: The deep breathing group

4-7-8 breathing technique Group

EXPERIMENTAL

The nightly state and trait anxiety scale and the PSSQ were applied to the 4-7-8 breathing group before the operation, and then they were given information about the 4-7-8 breathing technique. Between the 1st and 6th hours postoperatively, the 4-7-8 breathing technique was applied for 1 set (4 breaths) every hour. At the end of the 6th hour, the state anxiety scale and SSWS were administered.

Other: 4-7-8 breathing technique

control group

NO INTERVENTION

In the control group, the nightly state and trait anxiety scale and PSSQ were applied before the operation. At the end of the 6th hour postoperatively, without any application, the state anxiety scale and PSSQ were applied.

Interventions

The deep breathing group

The deep breathing group

4-7-8 breathing technique Group

4-7-8 breathing technique Group

Eligibility Criteria

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

You may qualify if:

  • years or older - 65 years or younger
  • Being on the 1st postoperative day
  • Have had bariatric surgery
  • No communication barrier
  • Have an ASA Score I or II

You may not qualify if:

  • Presence of major depression or psychosis
  • Having a communication barrier
  • Being transferred to another unit
  • Leaving work voluntarily

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, Palandöken, 25000, Turkey (Türkiye)

Location

Related Publications (1)

  • Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.

MeSH Terms

Conditions

Postoperative ComplicationsAnxiety Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMental 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
Principal Investigator

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 9, 2022

Study Start

January 1, 2022

Primary Completion

April 1, 2022

Study Completion

July 5, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations