Professor, School of Nursing, China Medical University Hospital, Principal Investigator
Phase: NA
Conditions: Lung Diseases
Sponsor: Wei-Fen Ma

 
ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt
Release Date: October 19, 2020
ClinicalTrials.gov ID: [Not yet assigned]
 
Study Identification
Unique Protocol ID: CMUH109-REC2-131
Brief Title: The Effectiveness of Acupressure for Managing Postoperative Pain and Anxiety
in Patients With Thoracoscopic Surgery.
Official Title: Professor, School of Nursing, China Medical University Hospital, Principal
Investigator.
Secondary IDs:
Study Status
Record Verification: October 2020
Overall Status: Recruiting
Study Start: September 20, 2020 [Actual]
Primary Completion: August 2021 [Anticipated]
Study Completion: September 2021 [Anticipated]
Sponsor/Collaborators
Sponsor: Wei-Fen Ma
Responsible Party: Sponsor-Investigator
Investigator: Wei-Fen Ma [lhdaisy]
Official Title: Professor, School of Nursing
Affiliation: China Medical University Hospital
Collaborators: China Medical University Hospital
Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
U.S. FDA IND/IDE: No
Human Subjects Review: Board Status: Approved
Approval Number: CMUH109-REC2-131
Board Name: Research Ethics Committee China Medical University and
Hospital, Taichung, Taiwan
Board Affiliation: China Medical University and Hospital
Phone: 886-4-22052121
Email:
Address:
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2 Yude Road, Taichung, 40447, Taiwan
Data Monitoring: No
FDA Regulated Intervention: No
Study Description
Brief Summary: 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.
Detailed Description: 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.
Conditions
Conditions: Lung Diseases
Keywords: acupressure
thoracoscopic surgery
acute pain
anxiety
comfort
Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: N/A
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Arms and Interventions
Arms
Assigned Interventions
Experimental: acupressure
After recruitment, participants will be randomized
to receive acupressure or control group. In the
acupressure
The acupressure involves the " Vaccaria Semen"
within skin-colored adhesive tape that placed on
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Arms
Assigned Interventions
acupressure group, participants will receive
acupressure treatment.
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.
No Intervention: routine care
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.
Outcome Measures
Primary Outcome Measure:
1.  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.
[Time Frame: 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]
Secondary Outcome Measure:
2.  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.
[Time Frame: 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.]
3.  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: 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.]
Other Pre-specified Outcome Measures:
4.  Analgesia Consumption
Injection time of morphine and ketorolac would be recorded.
[Time Frame: during the whole admission, an average of 4 day.]
5.  Comfort
as assessed by Shortened General Comfort Questionnaire
[Time Frame: 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]
6.  Heart rate variability
as assessed by Nexus-10, wireless Biofeedback/Neurofeedback system
[Time Frame: 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.]
7.  Early ambulation
The first ambulation time: act to walk with or without any kind of assistant after operation.
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[Time Frame: The first ambulation time after operation would be recorded, assessed up to 7 days.]
Eligibility
Minimum Age: 20 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria: Inclusion Criteria:
• pulmonary lung disease and will be scheduled to undergo a thoracoscopic
wedge resection, segmentectomy, or lobectomy.
• American Society of Anesthesiologist physical status of Classes I–II,
• both forearms without missing limbs or arteriovenous fistula
• ability to communicate in Taiwanese or Chinese, and
• agreement to participate in this study.
Exclusion Criteria:
• diagnosed as malignant neoplasm with lung meta,
• Had a stroke or peripheral vascular disease
• Platelet count less than 20 x 10^3/mm^3
• Using the patient controlled analgesia, and
• any known mental illness or memory dysfunction.
Contacts/Locations
Central Contact Person: Wei-Fen Ma, Ph.D
Telephone: 04-22053366 Ext. 7107
Email: lhdaisy@mail.cmu.edu.tw
Central Contact Backup: Wei-Fen Ma, Ph.D
Study Officials: Wei-Fen Ma, Ph.D
Study Principal Investigator
China Medical University, China
Locations: Taiwan
China Medical University
[Recruiting]
Taichung, Taiwan, 40447
Contact: Wei-Fen Ma, PHD 04-22053366 Ext. 7107  
lhdaisy@mail.cmu.edu.tw
Contact: Wei-Fen Ma, PHD 04-22053366 Ext. 7107   lhdaisy@gmail.com
Principal Investigator: Wei-Fen Ma, Ph.D
Sub-Investigator: Hsing-Chi Hsu, MSc
IPDSharing
Plan to Share IPD: No
-  Page 4 of 8  -

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-  Page 8 of 8  -

Cover page 
 
Official title: China Medical University Hospital 
 
NCT number: NCT04595253 
 
Title: The Effectiveness of Acupressure for Managing Postoperative Pain and 
Anxiety in Patients With Thoracoscopic Surgery 
 
 
 
Statistical Analysis Plan 
SPSS statistical software was used for data analysis, independent t test 
and chi-square test were used for descriptive analysis. A mixed model 
with repeated analysis was used to examine the effect of acupressure on 
pain, anxiety, and comfort. Regression analysis was to explore the 
influences of pain, anxiety, and comfort for study patients with 
thoracoscopic Surgery. 
 
 
Primary Completion Date 
The patient experienced moderate pain and anxiety after thoracoscopic 
surgery. There was no significant difference in demographic 
characteristics between the two groups before they received surgery. 
The experimental group, compared with the control group, pain intensity 
(p<0.01) and anxiety score (p<0.05) were statistically significant lower on 
day 1 and day 2 after intervention. The STAI-Y1 score (F=2.514, p=.086) 
and comfort level (F=2.953, p=.057) were no significant differences after 
intervention between two groups. The longer intervention, the 
significantly decreased pain intensity (p<0.05) for surgical procedures 
with lighter pain perception.