The Effectiveness of Acupressure for Managing Postoperative Pain and Anxiety in Patients With Thoracoscopic Surgery

July 27, 2021 updated by: Wei-Fen Ma

Professor, School of Nursing, China Medical University Hospital, Principal Investigator

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Wei-Fen Ma, Ph.D

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wei-Fen Ma, Ph.D
        • Sub-Investigator:
          • Hsing-Chi Hsu, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: acupressure
After recruitment, participants will be randomized to receive acupressure or control group. In the acupressure group, participants will receive acupressure treatment.
Other: acupressure
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain:Changes from baseline pain scale at post-operative day 2, after intervention.
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
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety
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.
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.
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.
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.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analgesia Consumption
Time Frame: during the whole admission, an average of 4 day.
Injection time of morphine and ketorolac would be recorded.
during the whole admission, an average of 4 day.
Comfort
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
as assessed by Shortened General Comfort Questionnaire
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
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.
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
Time Frame: The first ambulation time after operation would be recorded, assessed up to 7 days.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wei-Fen Ma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
China Medical University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wei-Fen Ma, Ph.D, China Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMUH109-REC2-131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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