## Protocol Section
### Identification Module
**NCT ID:** NCT06426329

**Brief Title:** The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety

**Official Title:** The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety

#### Organization Study ID Info
**ID:** TR SİVAS 04
#### Organization
**Class:** OTHER
**Full Name:** Cumhuriyet University
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-27
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cumhuriyet University

#### Responsible Party

**Investigator Affiliation:** Cumhuriyet University

**Investigator Full Name:** Sukran Ertekin Pinar

**Investigator Title:** Doç. Profesör Doktor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Aim: This study was planned to determine the effect of therapeutic touch applied at birth on pain, birth duration, traumatic birth perception and anxiety.

**Detailed Description:** Methods: The sample of this randomized controlled experimental research consisted of 66 (intervention group: 33; control group: 33) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Traumatic Childbirth Perception Scale.

### Conditions Module

**Conditions:**

- Pregnancy

- Vaginal Delivery

**Keywords:**

- Therapeutic Touch

- Labor Pain

- Birth Duration

- Anxiety

- Traumatic Birth Perception

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 66

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Therapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the latent phase of the first stage of labour, and the second was done in the active phase of labour.

**Intervention Names:**

- Behavioral: Therapeutic Touch

**Label:** Therapeutic touch Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group did not receive any treatment.

**Label:** Standard of care Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Therapeutic touch Group

**Description:** Therapeutic touch, as meaningful touch, is included in complementary medicine in the literature. It provides physical, emotional and spiritual relief, improves physiological health, makes the person feel valuable, gives confidence, peace, calmness and increases self-confidence.

**Name:** Therapeutic Touch

**Other Names:**

- Control Group

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain.

**Measure:** Visual Analogue Scale

**Time Frame:** Baseline

**Description:** It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety".

**Measure:** State Anxiety Inventory

**Time Frame:** Baseline

**Description:** It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth

**Measure:** Traumatic Birth Perception Scale

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain.

**Measure:** Visual Analogue Scale

**Time Frame:** Postpartum in 2 hour

**Description:** It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety".

**Measure:** State Anxiety Inventory

**Time Frame:** Postpartum in 2 hour

**Description:** It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth

**Measure:** Traumatic Birth Perception Scale

**Time Frame:** Postpartum in 2 hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Not having a high-risk pregnancy Having no health problems with the baby or herself Having a single foetus Being about to have a vaginal delivery Not having a chronic physical or psychiatric diagnosis Agreeing to participate in the research Not having communication and perception problems Miad (37W\<) pregnancy Having with induction application

Exclusion Criteria:

having vacuum, forceps etc. intervention such as

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sepinar09@gmail.com

**Name:** Sukran Ertekin Pinar, Ph.D.

**Phone:** 05342831124

**Role:** CONTACT

**Contact 2:**

**Email:** akkayab361@gmail.com

**Name:** Busra Akkaya

**Phone:** 05347880166

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sivas

**Contacts:**

***Contact 1:***

- **Email:** sepinar09@gmail.com

- **Name:** Sukran Ertekin Pinar

- **Phone:** +905342831124

- **Role:** CONTACT

***Contact 2:***

- **Name:** Busra Akkaya, MSc.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Turkey

**Facility:** Sukran Ertekin Pinar

**Status:** RECRUITING

**Zip:** 58140

#### Overall Officials

**Official 1:**

**Affiliation:** Cumhuriyet University

**Name:** Sukran Ertekin Pinar, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** There is not a plan to make IPD available.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007232

- Term: Infant, Newborn, Diseases

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M26008

- Name: Labor Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M5002

- Name: Birth Injuries

- Relevance: HIGH

- As Found: Traumatic Birth

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001720

- Term: Birth Injuries

### Misc Info Module

- Version Holder: 2024-05-31
