NCT06388005

Brief Summary

Research methods 1 Data collection and evaluation tools

  1. 1.The general data record sheet was self-designed by the research team, and the collected content included age, gender, BMI, occupation, general family status, economic situation, history of hypertension and cardiovascular diseases, history of anxiety and depression, self-rating anxiety scale (SAS) score, blood pressure and heart rate before and after intervention, disease diagnosis and severity, etc.
  2. 2.The anxiety was self-scored using the VAS-A (0-10 points), with 0 point as no anxiety and 10 as severe anxiety.
  3. 3.Negative emotional intensity was scored using the subjective unit of disturbance scale (SUDS, 0-10 points), with 0 point as no and 10 points as severe.
  4. 4.Nursing satisfaction was scored by the self-designed questionnaire (1-5 points): 5 points, very satisfied; 4 points, relatively satisfied; 3 points, satisfied; 2 points, medium; 1 point, dissatisfied.
  5. 5.Preparation stage The patients with VAS-A score ≥ 5 meeting the inclusion criteria were in a comfortable position with eyes closed, and adopted breathing exercise to relax their whole body. The patients were guided to summarize the main current distresses, such as fear, tension, pain, surgical prognosis, economic burden, etc., name the caused negative emotions, and use the SUDS to evaluate the intensity of negative emotions. The patients were asked to recite silently the prompt "Although I am very \*\* (a negative emotional word) now, I still deeply and completely love and accept myself" while tapping.
  6. 6.Tapping stage The patients were guided to gently massage the sore points on both sides of the body (2-3 fingers below the midpoint of the clavicle) with their five fingers together in a clockwise direction, while silently reciting the prompt 3 times. Then, the patients were guided to close their index and middle fingers together and gently tap the Zanzhu, Tongziliao, Chengqi, Renzhong, Chengjiang, Shufu, Dabao and Baihui acupoints successively with their fingertips at 2-3 times/s and the force they can bear. The prompt was recited silently when tapping each acupoint. After 3-5 rounds of tapping, 3 deep breaths were taken to re-evaluate the intensity of negative emotions.
  7. 7.Feedback stage After tapping, the patients communicated with the nurses at least once about their evaluated negative emotional intensity score and whether the score was accepted. If the tapping effect was not obvious, the evaluation was conducted by nurses, and the patients were guided to massage the sore points while silently reciting the prompt 3 times. To relieve reverse psychological drive, tapping was continued until the intensity of negative emotions reduced.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable anxiety

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

March 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 9, 2024

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • VAS-A score

    The anxiety was self-scored using the VAS-A (0-10 points), with 0 point as no anxiety and 10 as severe anxiety.

    before and 5 min after intervention

  • hemodynamic and endocrine indicators

    Hemodynamic and endocrine indicators includes systolic blood pressure, diastolic blood pressure, and heart rate

    before and 5 min after intervention

  • nursing satisfaction

    Nursing satisfaction was scored by the self-designed questionnaire (1-5 points): 5 points, very satisfied; 4 points, relatively satisfied; 3 points, satisfied; 2 points, medium; 1 point, dissatisfied.

    After nursing

Study Arms (2)

control group

NO INTERVENTION

experimental group

EXPERIMENTAL
Other: emotional freedom technique (EFT)

Interventions

The emotional freedom technique (EFT), founded by American scholar Gary Craig, is based on the methods of meridian science in traditional Chinese medicine (TCM) and Western psychology. Guided by the TCM theory of meridians, it quickly releases negative emotions by combining acupoint stimulation with neuro-linguistic programming, and its effectiveness has been confirmed by multiple studies.

experimental group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age of 18-64 years;
  • preoperative visual analog scale-anxiety (VAS-A) score (0-10 points) ≥ 5 points;
  • patients volunteer to participate in this study and signing the informed consent.

You may not qualify if:

  • mental disorders, disorders of consciousness;
  • restricted movement of the upper limbs and hands;
  • history of hypertension;
  • severe complications of the heart, brain and kidney;
  • history of anxiety, long-term use of anti-anxiety and anti-depression drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 29, 2024

Study Start

March 1, 2022

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations