The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting - Clinical Trial for Anxiety State | NCT06040411

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Acupressure

About this trial

This is an interventional supportive care trial for Anxiety State focused on measuring pain, ENT patients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Emergency ENT surgery, Refused to participate in the research, Did not sign the Informed Consent Form, Have a physical problem that prevents the application of acupressure to EX-HN3 (Yintang), LI4 and HT7 points, Diagnosed with anxiety, panic attacks and taking medication for anxiety, Previous surgical experience, Under 18 and over 65, People with vision, hearing and perception problems, unable to read and write Turkish, Have any problem that prevents them from communicating cognitively, emotionally and verbally, Experience in acupressure, Patients who have received sedative medication before surgical intervention didn't be included in the study. Exclusion Criteria: Emergency ENT surgery, Refused to participate in the research, Did not sign the Informed Consent Form, Diagnosed with anxiety, panic attacks and taking medication for anxiety, Previous surgical experience Under 18 and over 65, People with vision, hearing and perception problems, unable to read and write Turkish, Have any problem that prevents them from communicating cognitively, emotionally and verbally, Experience in acupressure, Patients who have received sedative medication before surgical intervention didn't be included in the study.

Sites / Locations

Tuğba ÇAM YANIK

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group (experimental)

Standard of care

Arm Description

The order of application was determined by lottery. HT7, LI4 and EX-HN3 points were applied respectively. Before starting the application, the area around to be pressurized was gently rubbed with the palm of the hand for 20-30 seconds. The surrounding tissue was relieved by rubbing gently. After rubbing, pressure was applied to the point determined based on the pain threshold level of each individual with a depth of 1-1.5 cm with the thumb for 5 seconds, rested for 2 seconds and the application was continued for 2 minutes. Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points).

Standard care was given.

Outcomes

Primary Outcome Measures

Anxiety evaluated using the State Anxiety Scale

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

Numerical Pain Scale

In this scale, the patient is asked to describe the severity of his/her pain in numbers, and the scale consists of a horizontal line, with "0" or "no pain" at the starting point and "10" or "unbearable pain" at the end point. The numbers from 0 to 10 are equally spaced on the horizontal line and 1-3 is defined as mild pain, 4-6 as moderate pain and 7-10 as severe pain.

Nausea and vomiting

The responses for each item are scored between zero (least discomfort) and four (most discomfort). The scores obtained from the eight items are summed to obtain a total score. The maximum score that can be obtained from the index is 32, which is also considered as the most severe symptom occurrence experience score.

Full Information

NCT ID

NCT06040411

First Posted

August 22, 2023

Last Updated

September 13, 2023

Sponsor

Mersin University

1. Study Identification

Unique Protocol Identification Number

NCT06040411

Brief Title

The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting

Acronym

Acupress

Official Title

The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting in ENT Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

June 1, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

The study was conducted in the ENT Clinic of Mersin Şehir Training and Research Hospital between June 1 and December 1, 2021, with a total of 60 adult patients, 30 in the study group and 30 in the control group, who met the inclusion and exclusion criteria.

Detailed Description

In the study, 60 patients were randomly assigned to the study and control groups. The study group (n = 30) included Shen Men, the 7th acupuncture point (HT7) of the heart meridian located between the ulna and pisiform bones on the radial side of the flexor carpi ulnaris tendon, EX-HN3 (Yintang) located in the middle of the beginning of both eyebrows and the thumb and the LI4 points located in the space between the index finger (between the 1st and 2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial side) were applied for an average of 15 minutes. No intervention didn't made to the control group (n = 30). The primary outcome of the study is the effect of acupressure on the state and trait anxiety level of patients. The secondary outcome of the study is the effect of acupressure on pain and nausea and vomiting level in patients. Anxiety levels of the patients were evaluated before and 15 minutes after acupressure application; pain levels were evaluated at the 4th postoperative hour, before going to bed at night (22.00), waking up in the morning (08.00) and at discharge; nausea and vomiting levels were evaluated in the first 24 hours after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety State, Pain, Vomiting, Nausea

Keywords

pain, ENT patients

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective, parallel, randomized controlled clinical trial

Masking

Outcomes Assessor

Masking Description

The statistician was blinded to analyze the data.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group (experimental)

Arm Type

Experimental

Arm Description

The order of application was determined by lottery. HT7, LI4 and EX-HN3 points were applied respectively. Before starting the application, the area around to be pressurized was gently rubbed with the palm of the hand for 20-30 seconds. The surrounding tissue was relieved by rubbing gently. After rubbing, pressure was applied to the point determined based on the pain threshold level of each individual with a depth of 1-1.5 cm with the thumb for 5 seconds, rested for 2 seconds and the application was continued for 2 minutes. Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points).

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

Standard care was given.

Intervention Type

Other

Intervention Name(s)

Acupressure

Other Intervention Name(s)

Acupress

Intervention Description

Acupressure was applied to each point for 2 minutes and the total application time was 15 minutes on average (for 5 points). During the application, the most appropriate position in which the individual would be comfortable was preferred, taking into account the privacy of the individual. First of all, the supine position was preferred, and alternatively, the sitting position was preferred. At the end of the application, it was ensured that the person was in a position that he/she was comfortable.

Primary Outcome Measure Information:

Title

Anxiety evaluated using the State Anxiety Scale

Description

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

Time Frame

Change from before implementation and immediately after, 15th minutes after implementation

Secondary Outcome Measure Information:

Title

Numerical Pain Scale

Description

In this scale, the patient is asked to describe the severity of his/her pain in numbers, and the scale consists of a horizontal line, with "0" or "no pain" at the starting point and "10" or "unbearable pain" at the end point. The numbers from 0 to 10 are equally spaced on the horizontal line and 1-3 is defined as mild pain, 4-6 as moderate pain and 7-10 as severe pain.

Time Frame

Change from the 4th hour after surgery, through the discharge, an average of 2 days

Title

Nausea and vomiting

Description

The responses for each item are scored between zero (least discomfort) and four (most discomfort). The scores obtained from the eight items are summed to obtain a total score. The maximum score that can be obtained from the index is 32, which is also considered as the most severe symptom occurrence experience score.

Time Frame

Change from surgery to the first 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Emergency ENT surgery, Refused to participate in the research, Did not sign the Informed Consent Form, Have a physical problem that prevents the application of acupressure to EX-HN3 (Yintang), LI4 and HT7 points, Diagnosed with anxiety, panic attacks and taking medication for anxiety, Previous surgical experience, Under 18 and over 65, People with vision, hearing and perception problems, unable to read and write Turkish, Have any problem that prevents them from communicating cognitively, emotionally and verbally, Experience in acupressure, Patients who have received sedative medication before surgical intervention didn't be included in the study. Exclusion Criteria: Emergency ENT surgery, Refused to participate in the research, Did not sign the Informed Consent Form, Diagnosed with anxiety, panic attacks and taking medication for anxiety, Previous surgical experience Under 18 and over 65, People with vision, hearing and perception problems, unable to read and write Turkish, Have any problem that prevents them from communicating cognitively, emotionally and verbally, Experience in acupressure, Patients who have received sedative medication before surgical intervention didn't be included in the study.

Overall Study Officials: