NCT07057518

Brief Summary

Type 2 diabetes is a major meatbolic condition. People living with Type 2 diabetes come across a wide range of health issues, including psychological health. Specifically, diabetes distress are in high levels among them. Diabetes distress is associated with psychological states such as anxiety, lower levels of self-care, and higher hemoglobin A1c (HbA1c) levels. The Emotional Freedom Technique consists of cognitive and somatic components and is used to heal an individual's negative emotions and manage associated emotional and physical disorders. The basic principle of this technique is to regulate the flow of energy by stimulating the meridian system and to relax the individual while focusing on the emotional reactions that lead to disability. Although the prevalence of psychological problems associated with T2DM and diabetes is increasing, there are not enough studies showing the effect of Emotional Freedom Technique on the psychological well-being of T2DM individuals.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

July 7, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

Type 2 diabetesEmotional Freedom TechniqueRCTs

Outcome Measures

Primary Outcomes (3)

  • WHO-5

    The WHO-5 scale is used to measure and evaluate an individual's emotion or happiness. The raw score is calculated by summing the five item scores and ranges from 0 to 25, with 0 representing the worst possible quality of life and 25 representing the best possible quality of life.

    Two months

  • Diabetes Stress Scale

    The scale is used to assess diabetes distress. The diabetes stress scale demonstrates good internal consistency, indicating that the component questions measure a similar construct. Higher scores-that is, scores above 3 on the diabetes stress scale-indicate greater levels of diabetes distress and have been found to be significantly associated with suboptimal lifestyle and higher HbA1c.

    Two months

  • General Anxiety Scale - 7

    The scale was used to measure the severity of anxiety symptoms. Total scores range from 0 to 21, with scores of 5, 10, and 15 representing mild, moderate, and severe anxiety thresholds, respectively, and were used to create a four-category ordinal variable. A cut-off point of 10 was used to distinguish between anxiety and no anxiety.

    Two months

Study Arms (2)

Emotional freedom technique group

EXPERIMENTAL

The EFT application will be implemented by the researcher who has been trained in this subject, in the most quiet and calm environment possible, in a position where the individuals are comfortable. There are basic steps to be followed in EFT application. Thought Field Therapy (TFT), developed by Callahan, based on Craig, uses different click points for specific psychological conditions, while EFT has 12 energy click points in the same specified order to treat every emotional problem, It is called 'Basic Recipe'

Behavioral: emotional freedom technique

Control group

NO INTERVENTION

No intervention was made to the people with Type 2 diabetes in the control group.

Interventions

The EFT application will be implemented by the researcher who has been trained in this subject, in the most quiet and calm environment possible, in a position where the individuals are comfortable. There are basic steps to be followed in EFT application. Thought Field Therapy (TFT), developed by Callahan, based on Craig, uses different click points for specific psychological conditions, while EFT has 12 energy click points in the same specified order to treat every emotional problem, It is called 'Basic Recipe'

Emotional freedom technique group

Eligibility Criteria

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

You may qualify if:

  • being over 18 years of age,
  • having type 2 diabetes,
  • no psychiatric diagnosis
  • agreeing to participate in the study.

You may not qualify if:

  • be under 18 years of age,
  • have type 1 diabetes or gestational diabetes,
  • attend any course on coping with diabetes distress and anxiety,
  • have advanced mental health problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Aycan ÇELİK ESMER, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The analysis of the research will be done by the other researcher, not by the researcher who applied it.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: People with Type 2 diabetes who meet the inclusion criteria for the research will use the Random.org website to allocate participants to the Emotional Freedom Technique and Control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 10, 2025

Study Start

May 6, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 10, 2025

Record last verified: 2025-05

Locations