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Lung DiseasesNCT04595253

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

A study testing acupressure in people with Lung Diseases, run by Wei-Fen Ma at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Lung Diseases
What is being tested?
acupressure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTaiwan
Study dates
20 Sep 2020to Sep 2021
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Wei-Fen Ma, Ph.D contact

04-22053366 Ext. 7107

lhdaisy@mail.cmu.edu.tw

Wei-Fen Ma, Ph.D contact

Taiwan1 site, 1 recruiting

  • China Medical University

    Taichung, 40447

    Wei-Fen Ma, PHD, 04-22053366 ext. 7107, lhdaisy@mail.cmu.edu.tw

    Wei-Fen Ma, PHD, 04-22053366 ext. 7107, lhdaisy@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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
Lung Diseases
Being tested
acupressure
Keywords
acupressure, thoracoscopic surgery, acute pain, anxiety, comfort
Medical subject headings
Lung Diseases, Acute Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acupressureOther

    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.

Study groups in NCT04595253
Study groupRoleWhat they receive
acupressureExperimentalAfter recruitment, participants will be randomized to receive acupressure or control group. In the acupressure group, participants will receive acupressure treatment.
Receives: Other: acupressure
routine careNo interventionAfter 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 outcomes (2)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start20 Sep 2020
  3. Primary completionAug 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04595253
Sponsor's protocol ID
CMUH109-REC2-131
Status last verified
Jul 2021
First submitted
9 Oct 2020
Last updated
2 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 12873949

  • Au DW, Tsang HW, Ling PP, Leung CH, Ip PK, Cheung WM. Effects of acupressure on anxiety: a systematic review and meta-analysis. Acupunct Med. 2015 Oct;33(5):353-9. doi: 10.1136/acupmed-2014-010720. Epub 2015 May 22.

    PubMed 26002571

  • Batvani M, Yousefi H, Valiani M, Shahabi J, Mardanparvar H. The Effect of Acupressure on Physiological Parameters of Myocardial Infarction Patients: A Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2018 Mar-Apr;23(2):143-148. doi: 10.4103/ijnmr.IJNMR_83_16.

    PubMed 29628963

  • Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth. 2002 Oct;49(8):792-8. doi: 10.1007/BF03017410.

    PubMed 12374706

  • Chang LH, Hsu CH, Jong GP, Ho S, Tsay SL, Lin KC. Auricular acupressure for managing postoperative pain and knee motion in patients with total knee replacement: a randomized sham control study. Evid Based Complement Alternat Med. 2012;2012:528452. doi: 10.1155/2012/528452. Epub 2012 Jul 10.

    PubMed 22844334

  • Chang S. The meridian system and mechanism of acupuncture: a comparative review. Part 3: Mechanisms of acupuncture therapies. Taiwan J Obstet Gynecol. 2013 Jun;52(2):171-84. doi: 10.1016/j.tjog.2013.04.005.

    PubMed 23915848

  • Chang S. The meridian system and mechanism of acupuncture-a comparative review. Part 1: the meridian system. Taiwan J Obstet Gynecol. 2012 Dec;51(4):506-14. doi: 10.1016/j.tjog.2012.09.004.

    PubMed 23276552

  • Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.

    PubMed 21869676

  • Chen T, Wang K, Xu J, Ma W, Zhou J. Electroacupuncture Reduces Postoperative Pain and Analgesic Consumption in Patients Undergoing Thoracic Surgery: A Randomized Study. Evid Based Complement Alternat Med. 2016;2016:2126416. doi: 10.1155/2016/2126416. Epub 2016 Mar 17.

    PubMed 27073400

  • Coutaux A. Non-pharmacological treatments for pain relief: TENS and acupuncture. Joint Bone Spine. 2017 Dec;84(6):657-661. doi: 10.1016/j.jbspin.2017.02.005. Epub 2017 Feb 20.

    PubMed 28219657

  • Danoff JR, Goel R, Sutton R, Maltenfort MG, Austin MS. How Much Pain Is Significant? Defining the Minimal Clinically Important Difference for the Visual Analog Scale for Pain After Total Joint Arthroplasty. J Arthroplasty. 2018 Jul;33(7S):S71-S75.e2. doi: 10.1016/j.arth.2018.02.029. Epub 2018 Feb 22.

    PubMed 29567002

  • Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

    PubMed 8598068

  • Endler NS, Kocovski NL. State and trait anxiety revisited. J Anxiety Disord. 2001 May-Jun;15(3):231-45. doi: 10.1016/s0887-6185(01)00060-3.

    PubMed 11442141

  • Engen DJ, Carns PE, Allen MS, Bauer BA, Loehrer LL, Cha SS, Chartrand CM, Eggler EJ, Cutshall SM, Wahner-Roedler DL. Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial. Complement Ther Clin Pract. 2016 May;23:141-8. doi: 10.1016/j.ctcp.2015.04.002. Epub 2015 Apr 20.

    PubMed 25935320

Questions about this trial

What is this clinical trial studying?

A study testing acupressure in people with Lung Diseases, run by Wei-Fen Ma at 1 site in Taiwan.

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 5 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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei-Fen Ma, Ph.D (04-22053366 Ext. 7107, lhdaisy@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT04595253, which also lists 42 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 2 Aug 2021.

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