## Protocol Section
### Identification Module
**NCT ID:** NCT06415240

**Brief Title:** Effect of Facilitated Tucking and Gentle Human Touch on Procedural Pain Among Neonates

**Official Title:** Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit

#### Organization Study ID Info
**ID:** STMU
#### Organization
**Class:** OTHER
**Full Name:** Shifa Tameer-e-Millat University
### Status Module
#### Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

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

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shifa Tameer-e-Millat University

#### Responsible Party

**Investigator Affiliation:** Shifa International Hospital

**Investigator Full Name:** Nazma Hamid

**Investigator Title:** Assistant Clinical Nurse Manager

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a Randomized Control Trial intended to investigate the effect of two non-pharmacological interventions on procedural pain among neonates.

**Detailed Description:** The Study Design is a Randomized Control Trial, intended to investigate the effect of facilitated tucking and gentle human touch on procedural pain among neonates (age 28 days). Neonatal Infant Pain Scale will be used for pain scoring, data will be collected by recording demographic variables for all neonates and then capturing a video recording for pain scoring by an independent research assistant.

### Conditions Module

**Conditions:**

- Non Pharmacological Pain Management

**Keywords:**

- Non Pharmacological Pain Management

- Neonates

- Procedural Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized Control Trial

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** As participants are neonates, they are not able to judge any intervention. Data is being collected by an independent data collector and pain scoring is also planned to be done by an independent Research Assistant. So, an investigator is masked.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 159

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A non pharmacological intervention to be implemented during arterial prick.

**Intervention Names:**

- Other: Facilitated Tucking

**Label:** Facilitated Tucking

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A non pharmacological intervention to be implemented during arterial prick.

**Intervention Names:**

- Other: Gentle Human Touch

**Label:** Gentle Human Touch

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Usual Care

**Label:** Usual Care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Facilitated Tucking

**Description:** Facilitated Tucking is a position to be adopted for pain relief in neonates.

**Name:** Facilitated Tucking

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Gentle Human Touch

**Description:** while gentle human touch is caressing on head for pain relief.

**Name:** Gentle Human Touch

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** scoring of pain based on a scale used in neonates both for term and pre term babies.( Minimum Pain Score 0, Maximum 7, Higher number indicates the worse outcome

**Measure:** Neonatal Infant Pain Scale

**Time Frame:** Before,During Arterial Prick and after three minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Both term and preterm neonates.
2. APGAR scores of a minimum of 6 at one minute and 8 at 5 minutes
3. Admitted to the Neonatal Intensive Care Unit
4. Undergoing arterial prick for the first time.

Exclusion Criteria:

1. Documented birth asphyxia
2. Congenital anomalies
3. Neurological diagnosis,
4. ventilated with paralysis
5. Extremely premature newborns (Gestational age \< 28 weeks)

**Maximum Age:** 28 Days

**Minimum Age:** 1 Day

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nazmahamid07@gmail.com

**Name:** Nazma Hamid, MSN

**Phone:** 03421547629

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Islamabad

**Contacts:**

***Contact 1:***

- **Email:** nazmahamid07@gmail.com

- **Name:** Nazma Hamid, MSN

- **Phone:** 03421547629

- **Role:** CONTACT

**Country:** Pakistan

**Facility:** Shifa Tameer E Millat University

**Zip:** 44000

#### Overall Officials

**Official 1:**

**Affiliation:** Shifa Tameer E Millat Univesrity

**Name:** Nazma Hamid, MSN

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Not intended

**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: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M1219

- Name: Pain, Procedural

- Relevance: HIGH

- As Found: Procedural Pain

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000073818

- Term: Pain, Procedural

### Misc Info Module

- Version Holder: 2024-05-31
