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| Name | Class |
|---|---|
| China Medical University Hospital | OTHER |
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The purpose of this study is to explore the effectiveness of acupressure for managing postoperative pain, anxiety, analgesia consumption, early ambulation, and comfort in patients with thoracoscopic surgery.
Thoracoscopic surgery is the surgical used to removal of a section or a segment of a lung lobe. One US national survey reported that 80% of patients undergoing pulmonary surgery experienced acute pain. 75-86% of these patients pointed out that experienced moderate, severe, or extreme pain, especially, on the 1st day after thoracoscopic surgery. However, inappropriate pain management after surgery is associated with limited the healing process, increased workload of heart, prolonged pulmonary rehabilitation, and increased medical costs, and can be a prediction of developing chronic pain. Acupressure is a nonpharmacological treatment for the management of postoperative pain. Recent studies have found that the application of acupressure is effective in decreasing operative pain intensity, morphine related side effects, and opioid consumptions after surgery. However, there was no further research about the role of acupressure applied to thoracoscopic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupressure | Experimental | After recruitment, participants will be randomized to receive acupressure or control group. In the acupressure group, participants will receive acupressure treatment. |
|
| routine care | No Intervention | After recruitment, participants will be randomized to receive acupressure or control group. In the control group, participants will receive routine care, including routine pain control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupressure | Other | The acupressure involves the " Vaccaria Semen" within skin-colored adhesive tape that placed on the "Neiguan" and "Shenmen" acupoints as an intervention measure. Continue to massage the acupoints with fingertips for 10 minutes, 3 times per day (8 and 12 in the morning, and 4 in the afternoon) . The adhesive tape will be retained in situ for 2 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain:Changes from baseline pain scale at post-operative day 2, after intervention. | as assessed by Visual Analogue Scale-Pain (VAS-P). The VAS-P scale is comprised of a horizontal line 100mm long with the indication "no pain" to the left and "worst possible pain" to the right. possible scores varied between 0-100. A higher scores mean a worse outcome. | Measure at before operation day, 7 post meridiem (PM), before operation; post-operative day1, 8 ante meridiem (AM), before intervention; post-operative day 1, 5 PM, after intervention; and post-operative day 2, 5 PM, after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | as assessed by Visual Analogue Scale-Anxiety(VAS-A). The VAS-A scale is comprised of a horizontal line 100mm long with the indication "no anxiety" to the left and "worst possible anxiety" to the right. possible scores varied between 0-100. A higher scores mean a worse outcome. | Measure at before operation day, 7 post meridiem (PM), before operation; post-operative day1, 9 ante meridiem (AM), before intervention; post-operative day 1, 5 PM, after intervention; and post-operative day 2, 5 PM, after intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia Consumption | Injection time of morphine and ketorolac would be recorded. | during the whole admission, an average of 4 day. |
| Comfort | as assessed by Shortened General Comfort Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-Fen Ma, Ph.D | Contact | 04-22053366 Ext. 7107 | lhdaisy@mail.cmu.edu.tw | |
| Wei-Fen Ma, Ph.D | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Wei-Fen Ma, Ph.D | China Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University | Recruiting | Taichung | 40447 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Amico, T. A. D. (2007). Thoracoscopic Lobectomy. Journal of Medical Sciences, 27(3), 95-100. https://doi.org/10.6136/JMS.2007.27(3).095 | ||
| 12873949 | Background | Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E. | |
| 26002571 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2020 | Jul 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D059787 | Acute Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Anxiety | as assessed by State-Trait Anxiety Inventory (STAI) Y form (STAI-Y1). It is 20 questions, which were rated from 1-4. Possible scores varied between 20-80. A STAI-Y1 score>40 as evidence of a state of anxiety. | Time Frame: Measure at before operation day, 7 post meridiem (PM), before operation; post-operative day1, 8 ante meridiem (AM), before intervention; and post-operative day 2, post meridiem (PM), after intervention. |
| Measure at before operation day,7 post meridiem (PM), before operation; post-operative day 1, 8 ante meridiem (AM), before intervention; and post-operative day 2, 5pm, after intervention |
| Heart rate variability | as assessed by Nexus-10, wireless Biofeedback/Neurofeedback system | Measure at before operation day, 7 post meridiem (PM), before operation; post-operative day1, 8 ante meridiem (PM), before intervention; post-operative day 1, 5 post meridiem (PM), after intervention; and post-operative day 2, 5 PM, after intervention. |
| Early ambulation | The first ambulation time: act to walk with or without any kind of assistant after operation. | The first ambulation time after operation would be recorded, assessed up to 7 days. |
| Background |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |