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The Effect of Diaphragmatic Breathing Exercise on Pain, Anxiety, and Depression

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ClinicalTrials.gov Identifier: NCT04225169
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Figen EROL URSAVAŞ, Çankırı Karatekin University

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.


Condition or disease Intervention/treatment Phase
Breathing Exercises Other: Breathing exercises Not Applicable

Detailed Description:

TKR is one of the most common orthopedic surgical procedures. Because TKR involves extensive muscle and bone repair, it is known to be one of the most painful operations. Moreover, as prosthetic surgery is an elective procedure, patients delay and experience anxiety about surgery due to their experiences with severe pain. This leads to chronic fear of pain and negative thought patterns. Inadequate use of analgesics and poor pain management after surgery can cause delayed mobilization, increased risk of venous thrombosis, insufficient wound healing, prolonged hospital stay, unnecessary psychological distress, and lower patient satisfaction. Many patients experience psychological problems such as depression, anxiety, discouragement, negative feelings, crying, frustration, lack of motivation, fatigue, moodiness, irritability, despair, and helplessness. Patients have expressed a need for social or psychological support. In order for patients to avoid such pain-related complications, they must be taught how to cope with pain.

The severe pain, anxiety, and stress patients experience following TKR surgery may impact their postoperative recovery. Studies have shown that nonpharmacological interventions for postoperative pain reduce pain intensity and opioid use. One of these nonpharmacological methods is diaphragmatic breathing exercises (DBE). Also known as diaphragmatic breathing or deep breathing, DBE is an effective holistic mind-body training to cope with stress and psychosomatic conditions. DBE involves contraction of the diaphragm and expansion of the belly to deepen inhalation and exhalation, which consequently decreases breathing rate and maximizes blood gas concentrations.

DBE plays an important role in pain signaling, autonomic activation, emotional regulation, acid-base equilibrium, and anti-inflammatory processes. DBE has been shown to enhance emotions, effectively reduce anxiety and its symptoms, and alleviate negative emotions such as depression, stress, and anger. There are few studies in the literature on the effect of DBE on patients who underwent TKR. One of these is a semi-experimental study that evaluated the effect of relaxation intervention (breathing exercises and guided imagery) on patients who underwent TKR. They authors reported that relaxation techniques were effective in managing patients' pain and anxiety. Another study evaluating the effect of relaxation techniques and back massage in patients who underwent TKR and total hip replacement (THR) showed that these techniques reduced patients' pain and anxiety during bedrest. Investigated the effect of a DBE program in patients with OA and found that DBE had no effect in alleviating pain or improving physical function.

A few studies have used DBE to prevent pain and sensory tension in patients who underwent TKR. However, different relaxation techniques were used in addition to DBE in these studies. To the best of our knowledge, no studies have examined the efficacy of DBE alone. Given the rising incidence of TKR, it is imperative that we strengthen our arsenal of effective interventions against the pain and psychological problems associated with this procedure. The aim of the present study was to evaluate the effect of DBE on pain, anxiety, and depression in patients who underwent TKR.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Breathing Exercise on Pain, Anxiety, and Depression
Actual Study Start Date : May 23, 2019
Actual Primary Completion Date : July 23, 2019
Actual Study Completion Date : August 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Exercises
diaphragmatic breathing exercises
Other: Breathing exercises
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:

No Intervention: Control
Patients in the control group received routine patient care consisting of cold therapy



Primary Outcome Measures :
  1. Comparison of mean postoperative pain scores of patients in the intervention and control groups [ Time Frame: The intervention and control groups completed the VAS (Visuel Analog Scale) was applied at postoperative 1, 2, 4, 8, 12, and 24 hours ]
    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

  2. Comparison of mean postoperative anxiety and depression scores of patients in the intervention and control groups [ Time Frame: HADS (Hospital Anxiety Depression Scale) was used on postoperative day 2 ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   In 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.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Having total knee replacement

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225169


Locations
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Turkey
Cankırı Karatekin University
Cankiri, Turkey
Sponsors and Collaborators
Çankırı Karatekin University
Investigators
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Study Chair: Figen Erol Ursavaş, Dr Çankırı Karatekin University
Publications:

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Responsible Party: Figen EROL URSAVAŞ, Faculty of Health Science, Department of Surgical Nursing, Çankırı Karatekin University
ClinicalTrials.gov Identifier: NCT04225169    
Other Study ID Numbers: CankırıKU
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Figen EROL URSAVAŞ, Çankırı Karatekin University:
Pain
Anxiety
Depression
Additional relevant MeSH terms:
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Respiratory Aspiration
Depression
Behavioral Symptoms
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes