Clinical trial NCT04225169: The Effect of Diaphragmatic Breathing Exercise on Pain, Anxiety, and Depression
Official title: The Effect of Breathing Exercise on Pain, Anxiety, and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathing Exercises
Keywords: Pain
Anxiety
Depression
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* Having total knee replacement

Exclusion Criteria:

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

Primary outcomes:
measure: Comparison of mean postoperative pain scores of patients in the intervention and control groups
timeFrame: The intervention and control groups completed the VAS (Visuel Analog Scale) was applied at postoperative 1, 2, 4, 8, 12, and 24 hours
measure: Comparison of mean postoperative anxiety and depression scores of patients in the intervention and control groups
timeFrame: HADS (Hospital Anxiety Depression Scale) was used on postoperative day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Cankiri
country: Turkey
facility: Cankırı Karatekin University
Study officials:
affiliation: Çankırı Karatekin University
name: Figen Erol Ursavaş, Dr
role: STUDY_CHAIR
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