NCT04225169

Brief Summary

Background: After total knee replacement (TKR) surgery, patients often experience intense levels of pain, stress, and anxiety that can adversely affect postoperative recovery. Diaphragmatic breathing exercise (DBE) may help patients manage pain and emotional distress. Aim: The aim of this study was to investigate the effect of DBE on pain, anxiety, and depression in patients undergoing TKR. Methods: The study population consisted of patients who underwent TKR surgery in the orthopedic ward of Çankırı State Hospital between May and August 2019. The study sample included a total of 38 patients satisfying the inclusion criteria. Stratified randomization was used to assign the patients into sex-matched intervention group (n=19) and control group (n=19). Patients in the intervention group were also trained in the DBE procedure. Pain scores were evaluated at 1, 2, 4, 8, 12, and 24 hours postoperatively, while the anxiety and depression was applied on the postoperative day 2. Data were analyzed using descriptive statistics, Chi-square test, and Mann-Whitney U test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 6, 2020

Last Update Submit

January 8, 2020

Conditions

Keywords

PainAnxietyDepression

Outcome Measures

Primary Outcomes (2)

  • Comparison of mean postoperative pain scores of patients in the intervention and control groups

    Visuel Analog Scale (VAS) This one-dimensional measure of pain intensity is a reliable and easily applicable scale that is widely accepted in the literature. VAS is used to convert nonmeasurable variables into numeric values. The 10-cm scale is labeled 0 ("no pain") at one end and 10 ("extreme pain") at the other, with values indicated at each cm in between

    The intervention and control groups completed the VAS (Visuel Analog Scale) was applied at postoperative 1, 2, 4, 8, 12, and 24 hours

  • Comparison of mean postoperative anxiety and depression scores of patients in the intervention and control groups

    Hospital Anxiety Depression Scale (HADS) The scale consists of 14 items, 7 of which assess signs of depression and 7 that assess signs of anxiety. Responses are evaluated on 4-point Likert-type scale scored between 0 and 3. However, responses to the even-numbered items decrease in severity and are scored from 3 to 0, while responses to the odd-numbered items are scored from 0 to 3. The sum of the odd-numbered items gives the anxiety score and the sum of the even-numbered items gives the depression score. The total score is not calculated. Minimum score 0, maximum score 42 higher scores mean a worse outcome.

    HADS (Hospital Anxiety Depression Scale) was used on postoperative day 2

Study Arms (2)

Exercises

EXPERIMENTAL

diaphragmatic breathing exercises

Other: Breathing exercises

Control

NO INTERVENTION

Patients in the control group received routine patient care consisting of cold therapy

Interventions

The patient was taken to a quiet room and asked to lie on the bed. For the first 5 minutes, the researchers explained how the exercise is done with pictures and demonstrated it to the patient. The patient was asked to perform the exercise for 5 minutes under supervision by the researchers. If the patient performed DBE correctly, practice was discontinued. If not, the patient was asked to practice for another 5 minutes. If the patient still could not perform the exercise correctly at the end of this time, they were excluded from the sample. DBE was performed according to the Cleveland Clinic guideline as follows:

Exercises

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsIn light of population-based research demonstrating higher prevalence of pain among women (Fillingim et al., 2009), the patients were first stratified by sex. Block randomization was then performed by coin-flipping method to assign the patients in equal numbers to one of the two study groups.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having total knee replacement

You may not qualify if:

  • Dementia,
  • Alzheimer's disease,
  • Chronic obstructive pulmonary disease,
  • Psychiatric disorders,
  • hearing problems that prevented communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cankırı Karatekin University

Çankırı, Turkey (Türkiye)

Location

Related Publications (10)

  • Lim YC, Yobas P, Chen HC. Efficacy of relaxation intervention on pain, self-efficacy, and stress-related variables in patients following total knee replacement surgery. Pain Manag Nurs. 2014 Dec;15(4):888-96. doi: 10.1016/j.pmn.2014.02.001. Epub 2014 Jun 21.

    PMID: 24957817BACKGROUND
  • Gatlin CG, Schulmeister L. When medication is not enough: nonpharmacologic management of pain. Clin J Oncol Nurs. 2007 Oct;11(5):699-704. doi: 10.1188/07.CJON.699-704.

    PMID: 17962177BACKGROUND
  • Pellino TA, Gordon DB, Engelke ZK, Busse KL, Collins MA, Silver CE, Norcross NJ. Use of nonpharmacologic interventions for pain and anxiety after total hip and total knee arthroplasty. Orthop Nurs. 2005 May-Jun;24(3):182-90; quiz 191-2. doi: 10.1097/00006416-200505000-00005.

    PMID: 15928526BACKGROUND
  • Lehrer P, Karavidas MK, Lu SE, Coyle SM, Oikawa LO, Macor M, Calvano SE, Lowry SF. Voluntarily produced increases in heart rate variability modulate autonomic effects of endotoxin induced systemic inflammation: an exploratory study. Appl Psychophysiol Biofeedback. 2010 Dec;35(4):303-15. doi: 10.1007/s10484-010-9139-5.

    PMID: 20635134BACKGROUND
  • Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med. 2012 Feb;13(2):215-28. doi: 10.1111/j.1526-4637.2011.01243.x. Epub 2011 Sep 21.

    PMID: 21939499BACKGROUND
  • Chalaye P, Goffaux P, Lafrenaye S, Marchand S. Respiratory effects on experimental heat pain and cardiac activity. Pain Med. 2009 Nov;10(8):1334-40. doi: 10.1111/j.1526-4637.2009.00681.x. Epub 2009 Aug 7.

    PMID: 19671085BACKGROUND
  • Hayama Y, Inoue T. The effects of deep breathing on 'tension-anxiety' and fatigue in cancer patients undergoing adjuvant chemotherapy. Complement Ther Clin Pract. 2012 May;18(2):94-8. doi: 10.1016/j.ctcp.2011.10.001. Epub 2011 Nov 9.

    PMID: 22500846BACKGROUND
  • Park E, Oh H, Kim T. The effects of relaxation breathing on procedural pain and anxiety during burn care. Burns. 2013 Sep;39(6):1101-6. doi: 10.1016/j.burns.2013.01.006. Epub 2013 Feb 1.

    PMID: 23375536BACKGROUND
  • Larsen KL, Brilla LR, McLaughlin WL, Li Y. Effect of Deep Slow Breathing on Pain-Related Variables in Osteoarthritis. Pain Res Manag. 2019 Jun 3;2019:5487050. doi: 10.1155/2019/5487050. eCollection 2019.

    PMID: 31281558BACKGROUND
  • Buyukyilmaz F, Asti T. The effect of relaxation techniques and back massage on pain and anxiety in Turkish total hip or knee arthroplasty patients. Pain Manag Nurs. 2013 Sep;14(3):143-54. doi: 10.1016/j.pmn.2010.11.001. Epub 2011 Jan 28.

    PMID: 23972865BACKGROUND

MeSH Terms

Conditions

PainAnxiety DisordersDepression

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Figen Erol Ursavaş, Dr

    Çankırı Karatekin University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Health Science, Department of Surgical Nursing

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 13, 2020

Study Start

May 23, 2019

Primary Completion

July 23, 2019

Study Completion

August 28, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations