Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level

Sponsor
Mersin University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05325307
Collaborator
(none)
60
2
15

Study Details

Study Description

Brief Summary

This randomized controlled study evaluates the effect of acupressure application on the anxiety level patients undergoing cystectomy surgery. The hypothesis of this study is that acupressure reduces anxiety levels and stabilizes hemodynamic parameters.

Condition or Disease Intervention/Treatment Phase
  • Other: Acupressure
  • Other: Placebo acupressure
N/A

Detailed Description

In the study, 60 patients will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 30), an average of 15 minutes will be applied to the HT7 (heart), LI4 (liver) and EX-NH3 (the point between the two eyes). In the placebo acupressure group (n = 30), the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, parallel, three-arm randomized controlled clinical trialProspective, parallel, three-arm randomized controlled clinical trial
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
In the study, a researcher (T.Ç.Y.) will determine the acupressure and placebo points to be applied to patients. However, the researcher (Z.Y.) who will apply acupressure and placebo acupressure be blinded without knowing whether these points are acupressure or placebo points. Participants will not know that they are in the acupressure or placebo group. When the research is completed, the data of the control and study groups (A or B) will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed by a statistician and the findings will be reported.
Primary Purpose:
Other
Official Title:
Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level: Three Blind Randomized Controlled Studies
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acupressure Group (experimental)

The experimental group will be given acupressure.

Other: Acupressure
The experimental group will start with HT7 points and continue LI4 and EX-NH3 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.

Placebo Comparator: Placebo Acupressure Group (control)

The placebo group will be given placebo acupressure

Other: Placebo acupressure
In the placebo acupressure group , the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes. Less pressure will be applied.

Outcome Measures

Primary Outcome Measures

  1. Anxiety evaluated using the State Anxiety Scale [Change from before implementation and immediately after, 20th minute after acupressure]

    Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high

Secondary Outcome Measures

  1. Systolic blood pressure [Change from before implementation and immediately after, 20th minute after acupressure]

    Systolic blood pressure (SBP), mmHg

  2. Diastolic blood pressure [Change from before implementation and immediately after, 20th minute after acupressure]

    Diastolic blood pressure (DBP), mmHg

  3. Heart rate [Change from before implementation and immediately after, 20th minute after acupressure]

    Beats per minute

  4. Respiratory rate [Change from before implementation and immediately after, 20th minute after acupressure]

    Lung breathing

  5. Peripheral oxygen saturation [Change from before implementation and immediately after, 20th minute after acupressure]

    %, percentage of oxygenated hemoglobin in peripheral arterial blood

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Agreeing to participate in the research (signing the Informed Consent Form),

  • Conscious and cooperative

  • Speaks and understands Turkish,

  • 18-65 years old,

  • Before surgery,

  • Stable general condition,

  • No sensitivity in the area where acupressure/placebo acupressure will be applied,

  • 15 July 2022 - 15 July 2023 hospitalized in the urology clinic,

  • No active COVID-19 infection,

  • Patients without any psychiatric diagnosis will be included.

Exclusion Criteria:
  • Those who do not agree to participate in the research (who do not sign the Informed Consent Form)

  • Conscious and uncooperative,

  • Not speaking or understanding Turkish,

  • Not between the ages of 18-65,

  • No surgical intervention planned,

  • The planned emergency surgical intervention,

  • Unstable general condition,

  • Sensitivity in the area where acupressure/placebo acupressure will be applied,

  • Active COVID-19 infection,

  • 15 July 2022 - 15 July 2023 who did not stay in the urology clinic,

  • Patients with current psychiatric diagnosis will not be included in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mersin University

Investigators

  • Study Director: Gülay Altun Ugras, PhD, Mersin University
  • Principal Investigator: Mualla Yılmaz, PhD, Mersin University
  • Principal Investigator: Zeliha Yaman, PhD, Mersin University
  • Principal Investigator: Naciye Balbay, graduate, Mersin University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tugba CAM YANIK, PhD Research Assistant, Mersin University
ClinicalTrials.gov Identifier:
NCT05325307
Other Study ID Numbers:
  • Mersin Univ
First Posted:
Apr 13, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022