## Protocol Section
### Identification Module
**NCT ID:** NCT06429254

**Brief Title:** The Effect of Emotional Freedom Techniques on Pelvic Pain

**Official Title:** Effect of Emotional Freedom Techniques on Pelvic Pain and Quality of Life in Women With Endometriosis: A Randomized Controlled Study

#### Organization Study ID Info
**ID:** 01/05
#### Organization
**Class:** OTHER
**Full Name:** Karabuk University
### Status Module
#### Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-27
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Karabuk University

#### Responsible Party

**Investigator Affiliation:** Karabuk University

**Investigator Full Name:** Ayse Cuvadar

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Pelvic pain caused by endometriosis is a common symptom and reduces women's quality of life.

EFT is a method that can be preferred in pelvic pain due to its ease of use and low cost.

Raising women's awareness for EFT

**Detailed Description:** Pelvic pain caused by endometriosis is a common symptom and reduces women's quality of life. EFT has become widely used in medical and psychological treatment settings in recent years.It is also used as a self-help technique by millions of people every year.EFT is a method that can be preferred in pelvic pain due to its ease of use and low cost.

### Conditions Module

**Conditions:**

- Woman

- Pelvic Pain

**Keywords:**

- Pelvic pain

- Woman

- quality of life

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 64

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** First, the Personal Information Form, Visual Analogue Scale, and Quality of Life Scale will be administered as pre-tests to the EFT group. A high score obtained from the quality of life scale indicates a high quality of life.

After the pre-tests, the first EFT session will be conducted. A second EFT session will take place 30 days later, followed by post-tests. During this period, affirmations will be provided as needed based on individual difficulties, perspectives, support systems, past traumas, and emotional blockages experienced by the woman. Each session is planned to last approximately 45 minutes to 1 hour.

Procedure: Administering pre-tests followed by the first EFT session. Procedure: After 30 days, conducting post-tests followed by the second EFT session.

Procedure: After another 30 days, only post-tests will be conducted.

**Intervention Names:**

- Other: Experimental group

**Label:** Emotional Freedom Techniques group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** After obtaining consent from the women included in the group, pre-tests will be conducted followed by breathing exercises. A program will be tailored according to the suitability of the women. Once an appropriate environment is provided for meeting with the women, information about the study will be provided. Pain coping methods will be explained, and breathing exercises will be taught. The exercises will commence when the woman feels ready. The breathing exercises typically last around 15-20 minutes.

With a plan for a total of 8 breathing exercises to be conducted over four weeks, consisting of 2 sessions per week, they will be scheduled to coincide with the EFT group, with sessions held every 5 days.

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Emotional Freedom Techniques group

**Description:** Life Scale will be administered as pre-tests to the EFT group. After the pre-tests, the first EFT session will be conducted. A second EFT session will take place 30 days later, followed by post-tests. During this period, affirmations will be provided as needed based on individual difficulties, perspectives, support systems, past traumas, and emotional blockages experienced by the woman. Each session is planned to last approximately 45 minutes to 1 hour.

**Name:** Experimental group

**Other Names:**

- EFT group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Emotional Freedom Techniques

**Measure:** Examining the Effect of Emotional Freedom Technique on Pelvic Pain İn Endometriosis

**Time Frame:** 1 time per month up to 2 months, Pain will be assessed using the VAS (Visual Analogue Scale). A high score on the scale indicates high pain.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Being diagnosed with endometriosis
2. Experiencing pelvic pain
3. Being between the ages of 18-49
4. Those whose symptom complaints are 5 or above on the visual analogue scale

Exclusion Criteria:

1. Patients with known systemic diseases (e.g. hypertension, diabetes, coronary, kidney and liver diseases);
2. Patients with known malignancy;
3. Women in menopause;
4. Having any obstacle to communication

**Gender Based:** True

**Gender Description:** Women

**Healthy Volunteers:** True

**Maximum Age:** 49 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Edirne

**Contacts:**

***Contact 1:***

- **Email:** aysecuvadar@karabuk.edu.tr

- **Name:** Ayşe Çuvadar

- **Phone:** 05536217689

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Trakya University

**Status:** RECRUITING

**Zip:** 22100

**Location 2:**

**City:** Edirne

**Contacts:**

***Contact 1:***

- **Email:** aysecuvadar@karabuk.edu.tr

- **Name:** Ayşe Çuvadar

- **Phone:** 05536217689

- **Role:** CONTACT

***Contact 2:***

- **Name:** Zuhal Guksu

- **Role:** SUB_INVESTIGATOR

**Country:** Turkey

**Facility:** Trakya University

**Status:** RECRUITING

**Zip:** 22100

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M19918

- Name: Pelvic Pain

- Relevance: HIGH

- As Found: Pelvic Pain

- ID: M7877

- Name: Endometriosis

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000017699

- Term: Pelvic Pain

### Misc Info Module

- Version Holder: 2024-05-31
