NCT06040411

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

Same day

First QC Date

August 22, 2023

Last Update Submit

September 13, 2023

Conditions

Keywords

painENT patients

Outcome Measures

Primary Outcomes (1)

  • 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

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

Secondary Outcomes (2)

  • Numerical Pain Scale

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

  • Nausea and vomiting

    Change from surgery to the first 24 hours

Study Arms (2)

Study Group (experimental)

EXPERIMENTAL

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).

Other: Acupressure

Standard of care

NO INTERVENTION

Standard care was given.

Interventions

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.

Also known as: Acupress
Study Group (experimental)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğba ÇAM YANIK

Yenişehir, Mersin, 33120, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPainVomitingNausea

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gülay ALTUN UĞRAŞ, PhD

    Mersin University

    STUDY DIRECTOR
  • Serpil YÜKSEL, PhD

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR
  • Bahar TAŞDELEN, PhD

    Mersin University

    PRINCIPAL INVESTIGATOR
  • Seda TÜRKİLİ, Doctor

    Mersin City Hospital

    PRINCIPAL INVESTIGATOR
  • Serkan TÜRKİLİ, Doctor

    Mersin City Hospital

    PRINCIPAL INVESTIGATOR
  • Ahmet KARAMAN, PhD

    Mersin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician was blinded to analyze the data.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, parallel, randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Research Assistant

Study Record Dates

First Submitted

August 22, 2023

First Posted

September 15, 2023

Study Start

June 1, 2021

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations