NCT06391268

Brief Summary

The main aim of the study was to investigate self-administered emotional to determine the effect of the freedom technique on pain and stress levels. The sub-objectives of the study are as follows:

  1. 1.To determine the effect of self-administration of EFT on pain level.
  2. 2.To determine the effect of self-administered EFT on stress level.
  3. 3.To determine the effect of EFT self-administration on comfort level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration 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

January 3, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 8, 2023

Last Update Submit

October 13, 2024

Conditions

Keywords

Fibromyalgia,Emotional free techniquepainstresscomfort

Outcome Measures

Primary Outcomes (2)

  • Comparison of the self-EFT group

    Comparison of the group to which EFT was performed by the researcher, Brief Scan for Stress and Problem List to assess stress and problems (Calculated out of 10 points, cut-off point is 4), Brief Pain Invertory to assess pain: The numeric pain scale is evaluated on a scale of 0-10, with "0" representing no pain and "10" representing excruciating pain. Each item is rated on a numerical scale from 0 to 10; "0" means not affected at all, "100" means completely affected). At the end of the study, pain and stress scores of the two experimental groups (EFT performed by the researcher and self-administered EFT) before and after EFT were analyzed and compared.

    up to 24 weeks

  • INVESTIGATION OF THE EFFECT OF SELF-APPLIED EMOTIONAL FREEDOM TECHNIQUE ON PAIN AND STRESS LEVELS IN FIBROMYALGIA PATIENTS

    It was determined that there was a statistically significant difference in stress thermometer measurements in the researcher-administered EFT, Self-EFT and Control groups according to time (p\<0.05). As a result, the hypotheses "H1: EFT application has an effect on the pain level of patients", "H2: EFT application has an effect on the stress level of patients", "H3: EFT application has an effect on the comfort level of patients", "H4: EFT application has an effect on the fibromyalgia level of patients" were accepted. As a result of the research, significant differences were determined in pain, stress and comfort levels in all application groups.

    INVESTIGATION OF THE EFFECT OF SELF-APPLIED EMOTIONAL FREEDOM TECHNIQUE ON PAIN AND STRESS LEVELS IN FIBROMYALGIA PATIENTS

Secondary Outcomes (2)

  • Control grouup

    up to 24 weeks

  • Control grouup

    The application areas of the thesis are from non-pharmacological treatments to complementary therapies.

Study Arms (3)

The group to whichEmotional freedom technique (EFT) EFT was applied by the researcher

EXPERIMENTAL

Emotional Freedom Technique (EFT) works on cognitive and energetic levels. While ensuring that the individual is conscious and aware of a disturbing symptom or discomfort, selected acupuncture points are touched at the same time, creating a cognitive transition and energetic release. 1-The group to which EFT was applied by the researcher

Behavioral: Emotional Freedom Technique (EFT) works on cognitive and energetic levels.

Emotional freedom technique (EFT) for fibromyalgia -2-The group that applies EFT to itself

EXPERIMENTAL

Emotional Freedom Technique (EFT) works on cognitive and energetic levels. While ensuring that the individual is conscious and aware of a disturbing symptom or discomfort, selected acupuncture points are touched at the same time, creating a cognitive transition and energetic release. 2-The group that applies EFT to itself

Behavioral: Emotional Freedom Technique (EFT) works on cognitive and energetic levels.

Emotional freedom technique (EFT) for fibromyalgia -3-Control group without EFT:

NO INTERVENTION

3-Control group without EFT: Pain, problem-stress, comfort and fibromyalgia scales were applied in 3 interviews.

Interventions

Emotional Freedom Technique (EFT) works on cognitive and energetic levels.

Also known as: Emotional freedom technique (EFT) for fibromyalgia
Emotional freedom technique (EFT) for fibromyalgia -2-The group that applies EFT to itselfThe group to whichEmotional freedom technique (EFT) EFT was applied by the researcher

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of fibromyalgia
  • Can speak and understand Turkish
  • Have time and place orientation
  • No psychiatric illness,
  • No vision and hearing problems.

You may not qualify if:

  • Unstable medical condition
  • Non-cooperative individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Buca Seyfi Demirsoy Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 1. Determination of Subjective Units of Discomfort (SUD) (The researcher scores the distress felt on a scale between zero and ten points). 2. Setup (The general structure of the setup sentence is "Despite this .........., I deeply and completely accept myself.") 3. Clicking the meridian points in sequence 4. Nine Gamut procedure (some eye movements, mumbling and counting while clicking on the Gamut point in the hand).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2023

First Posted

April 30, 2024

Study Start

January 3, 2022

Primary Completion

August 16, 2022

Study Completion

October 13, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations