Pain, Postoperative Clinical Trial
Official title:
The Effect of Foot Massage After Open Heart Surgery on Postoperative Pain, Sleep Quality and Mood of Patients
Verified date | October 2022 |
Source | Ataturk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The randomized controlled experimental study was conducted in the cardiovascular surgery clinic of Atatürk University Health Practice and Research Center between April 2021 and September 2021.The research sample consisted of 91 patients who met the research criteria. Since exclusion criteria were met in 15 patients during the research process, the study was completed with 76 patients. Descriptive Information Form, Visual Analog Scale, State-Trait Anxiety Scale, Visual Analog Sleep Scale and Hospital Anxiety and Depression Scale were used as data collection tools. All scales were applied to the patients preoperatively. According to the Postoperative Visual Analog Scale, the patients in the experimental group who stated that they had more than 4 pains were given foot massage for a total of 20 minutes, 10 minutes on each foot. After the surgery, classical foot massage was applied to the patients for 3 consecutive days, including the day they came to the service from the intensive care unit. One day after each application, the patients' pain, sleep quality and mood levels were examined. Data were collected by applying the same procedure steps without foot massage to the patients in the control group.
Status | Completed |
Enrollment | 76 |
Est. completion date | September 10, 2021 |
Est. primary completion date | April 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Those who agree to participate in the research - Those who have planned coronary artery bypass graft surgery between the specified dates - 18 years of age or older - Not having visual/verbal/auditory communication difficulties and mental disabilities that would prevent him/her from expressing the explained information correctly. - Hypertension under control - Those who state that they have 4 or more post-operative GCS pain - For patients in the experimental group; infectious disease of the foot skin, local infection, open lesion/wound, scar tissue, edema, hematoma, thrombophlebitis, deep vein thrombosis, coagulation disorder, varicose veins, osteoporosis, osteomyelitis, hepatitis, inflammatory and degenerative joint diseases, diabetes-induced neuropathy, toes patients without deformities, recent fractures, dislocations, ruptures of muscle fibers, tendons, or fascia Exclusion Criteria: ?Patients who develop any complications after surgery |
Country | Name | City | State |
---|---|---|---|
Turkey | Beyzanur Kiziloglu | Erzurum | Palandöken |
Lead Sponsor | Collaborator |
---|---|
Ataturk University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analog scale | The visual analog scale was used to evaluate the pain severity of the patient. It is a self-reported scale in the form of a 10-cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/her pain between 0 and 10, with 0 cm indicating "no pain" and 10 cm indicating "unbearable pain" | [Time Frame: up to 24 hours] | |
Primary | State-Trait Anxiety Inventory (STAI-I, STAI-II) | It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by O#ner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety). | [Time Frame: up to 24 hours] | |
Primary | Visual Comparison Sleep Scale | Scoring in this scale, whose Turkish version consists of 10 items, was formed by reversing the 2nd, 4th, 8th and 9th statements. Each item in the scale was evaluated by visual comparison technique by showing it on the chart between 0 (on the left end) and 100 (on the right end). The score obtained from the scale is between 0-1000. An increase in the score obtained from the scale indicates a decrease in sleep quality. | [Time Frame: up to 24 hours] | |
Primary | Hospital Anxiety and Depression Scale | It consists of two subscales, depression and anxiety. Each subscale includes 7 items. There are 14 items in total. While summing the scores of items 1, 3, 5, 7, 9, 11 and 13 for the Anxiety Subscale of the Hospital Anxiety and Depression Scale; For the Depression Sub-Scale, the scores of items 2, 4, 6, 8, 10, 12 and 14 are added. Items 3, 5, 6, 8, 10, 11, and 13 of the Anxiety Sub-Scale of the Hospital Anxiety and Depression Scale show gradually decreasing severity and are scored in a 4-point Likert scale as 3, 2, 1, 0. Items 2, 4, 7, 9, 12 and 14 of the Depression Subscale of the Hospital Anxiety and Depression Scale show increasing severity and are scored as 0, 1, 2, 3 on a 4-point Likert scale. The lowest score that patients can get from the Anxiety and Depression Subscales is 0, and the highest score is 21. | [Time Frame: up to 24 hours] |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05480111 -
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
|
Phase 4 | |
Completed |
NCT06129305 -
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
|
||
Completed |
NCT04401826 -
Micro-surgical Treatment of Gummy Smile
|
N/A | |
Recruiting |
NCT04020133 -
the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.
|
N/A | |
Completed |
NCT03023462 -
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
|
N/A | |
Completed |
NCT03652103 -
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
|
Phase 4 | |
Completed |
NCT03546738 -
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
|
N/A | |
Withdrawn |
NCT03528343 -
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
|
Phase 1/Phase 2 | |
Terminated |
NCT03261193 -
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
|
Phase 3 | |
Completed |
NCT02525133 -
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
|
Phase 3 | |
Completed |
NCT03244540 -
Regional Analgesia After Cesarean Section
|
Phase 4 | |
Enrolling by invitation |
NCT05316168 -
Post Operative Pain Management for ACL Reconstruction
|
Phase 3 | |
Recruiting |
NCT04130464 -
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
|
Phase 4 | |
Enrolling by invitation |
NCT04574791 -
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
|
N/A | |
Completed |
NCT04073069 -
Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults
|
Phase 4 | |
Completed |
NCT04526236 -
Influence of Aging on Perioperative Methadone Dosing
|
Phase 4 | |
Recruiting |
NCT05351229 -
Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
|
Phase 4 | |
Enrolling by invitation |
NCT05543109 -
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
|
N/A | |
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04919317 -
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
|
Phase 2 |