NCT04595253

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

October 9, 2020

Last Update Submit

July 27, 2021

Conditions

Keywords

acupressurethoracoscopic surgeryacute painanxietycomfort

Outcome Measures

Primary Outcomes (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.

    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)

  • Anxiety

    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: 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 Outcomes (4)

  • Analgesia Consumption

    during the whole admission, an average of 4 day.

  • Comfort

    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

    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.

  • +1 more other outcomes

Study Arms (2)

acupressure

EXPERIMENTAL

After recruitment, participants will be randomized to receive acupressure or control group. In the acupressure group, participants will receive acupressure treatment.

Other: acupressure

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.

Interventions

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.

acupressure

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, 40447, Taiwan

RECRUITING

Related Publications (42)

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Related Links

MeSH Terms

Conditions

Lung DiseasesAcute PainAnxiety Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Wei-Fen Ma, Ph.D

    China Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Fen Ma, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, School of Nursing

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 20, 2020

Study Start

September 20, 2020

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations