Breathing ExercisesNCT04225169
The Effect of Diaphragmatic Breathing Exercise on Pain, Anxiety, and Depression
A study testing Breathing exercises in people with Breathing Exercises, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breathing Exercises
- What is being tested?
- Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2019to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having total knee replacement
Who cannot join
- Dementia,
- Alzheimer's disease,
- Chronic obstructive pulmonary disease,
- Psychiatric disorders,
- hearing problems that prevented communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breathing Exercise on Pain, Anxiety, and Depression
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.
Read the 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.
- Conditions
- Breathing Exercises
- Being tested
- Breathing exercises
- Keywords
- Pain, Anxiety, Depression
- Medical subject headings
- Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesOther
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:
| Study group | Role | What they receive |
|---|---|---|
| Exercises | Experimental | diaphragmatic breathing exercises Receives: Other: Breathing exercises |
| Control | No intervention | Patients in the control group received routine patient care consisting of cold therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: HADS (Hospital Anxiety Depression Scale) was used on postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start23 May 2019
- Primary completion23 Jul 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen EROL URSAVAŞ, Çankırı Karatekin University
- Investigators
- Figen Erol Ursavaş, Dr, Study chair, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225169
- Sponsor's protocol ID
- CankırıKU
- Status last verified
- Jan 2020
- First submitted
- 6 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24957817Gatlin 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.
PubMed 17962177Pellino 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.
PubMed 15928526Lehrer 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.
PubMed 20635134Busch 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.
PubMed 21939499Chalaye 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.
PubMed 19671085Hayama 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.
PubMed 22500846Park 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.
PubMed 23375536Larsen 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.
PubMed 31281558Buyukyilmaz 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.
PubMed 23972865
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercise on Pain, Anxiety, and Depression
- ClinicalTrials.gov ID
- NCT04225169
- Acronym / sponsor ID
- CankırıKU
- Conditions
- Breathing Exercises
- Keywords
- Pain, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises | Experimental | Other: Breathing exercisesdiaphragmatic breathing exercises |
| Control | No intervention | –Patients in the control group received routine patient care consisting of cold therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Having total knee replacement
Key exclusion criteria (5 listed)
- Dementia,
- Alzheimer's disease,
- Chronic obstructive pulmonary disease,
- Psychiatric disorders,
- hearing problems that prevented communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exercisesThe 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: | Other | Exercises |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 24957817Lim 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.
- Background: PubMed 17962177Gatlin 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.
- Background: PubMed 15928526Pellino 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.
- Background: PubMed 20635134Lehrer 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.
- Background: PubMed 21939499Busch 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.
- Background: PubMed 19671085Chalaye 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.
- Background: PubMed 22500846Hayama 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.
- Background: PubMed 23375536Park 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.
- Background: PubMed 31281558Larsen 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.
- Background: PubMed 23972865Buyukyilmaz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Figen Erol Ursavaş, Dr study chair
Çankırı Karatekin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercises in people with Breathing Exercises, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225169, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.