## Protocol Section
### Identification Module
**NCT ID:** NCT06417047

**Brief Title:** Effect of Hand Holding on Pain and Anxiety

**Official Title:** Effect of Hand Holding on Reducing Intramuscular Injection-Induced Pain and Anxiety: A Randomized Controlled Study

#### Organization Study ID Info
**ID:** Necmettin Erbakan U
#### Organization
**Class:** OTHER
**Full Name:** Necmettin Erbakan University
### Status Module
#### Completion Date
**Date:** 2025-04-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-03

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Necmettin Erbakan University

#### Responsible Party

**Investigator Affiliation:** Necmettin Erbakan University

**Investigator Full Name:** Serpil SU

**Investigator Title:** Assistant professors

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** It was aimed to examine the effect of the hand holding method applied during intramuscular injection on pain and anxiety.

**Detailed Description:** This study was designed as a pre-test-post-test regular parallel group, randomized controlled experimental design. The research will be carried out in the Adult Emergency Service of the Ministry of Health of the Republic of Turkey, Konya City Hospital. Patients will be randomly divided into two groups: handholding (52) and control group (52). For the Hand Holding Group: After the patient is positioned appropriately, the patient's hand will be held by the researcher. Once the intramuscular injection is completed, the patient's hand holding will be stopped. For the Control Group: No application will be made during intramuscular injection in the control group. The primary outcome of this study is to determine patients' pain scores during the intramuscular injection procedure. The secondary outcome is to determine the anxiety levels of patients.

### Conditions Module

**Conditions:**

- Pain and Anxiety

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Parallel Assignment

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Double (Participant, Outcomes Assessor) The patients will be informed about the study and their consent will be obtained without explaining which group they are in. Since the researcher manages the implementation process of the study, researcher blinding cannot be done. In addition, it will be ensured that the researcher learns which group the patients are in after the patients accept to participate in the study. Thus, the internal validity of the research will be ensured.

At the same time, blind technique will be applied in terms of statistical analysis in the research. The data will be recorded on the computer by the researcher without using the expression of experimental and control groups, and data analysis will be done by another statistician other than the person who made the randomization.

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 104

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In the experimental group, hand holding will be done by the researcher, and intramuscular injection will be done by the clinical nurse. All intramuscular injections will be performed by a single nurse and the ventrogluteal region will be used as the injection site. Patients will first fill out the Voluntary Information and Consent Form, and then the Descriptive Characteristics Form and State Anxiety Scale. After the injection site is evaluated, the researcher will hold the patient's hand, the nurse will enter the tissue at a 90-degree angle and administer the drug slowly (1 ml/10 seconds). After removing the needle from the tissue, the nurse will apply pressure with dry cotton, and then the researcher will stop holding the patient's hand. After the procedure, the Numerical Pain Scale and State Anxiety Scale will be filled in within 1 minute.

**Intervention Names:**

- Other: Hand Holding

**Label:** Hand Holding Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** In the control group, intramuscular injection will be performed by the clinic nurse. All intramuscular injections will be performed by a single nurse and the ventrogluteal region will be used as the injection site. Patients will first fill out the Voluntary Information and Consent Form, and then the Descriptive Characteristics Form and State Anxiety Scale. After the injection site is assessed, the nurse will enter the tissue at a 90-degree angle and administer the medication slowly (1 ml/10 seconds). After removing the needle from the tissue, the nurse will apply pressure with dry cotton. After the procedure, the Numerical Pain Scale and State Anxiety Scale will be filled in within 1 minute.

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hand Holding Group

**Description:** During the intramuscular injection, the aim is to draw the patients' attention elsewhere by holding their hand.

**Name:** Hand Holding

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** A score of "0" indicated the lowest pain, and a score of "10" indicated the highest pain.

**Measure:** Numerical Pain Scale

**Time Frame:** It will be filled within 1 minute after the intramuscular injection is completed.

#### Secondary Outcomes

**Description:** A score between 20-80 is obtained. The highest score obtained from the scale indicates a high level of anxiety, while a low score indicates a low level of anxiety.

**Measure:** State Anxiety Scale

**Time Frame:** It will be filled immediately before the intramuscular injection and within 1 minute after the procedure is completed.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Having vitamin B 12 1000 mcg/ml (1 ml ampoule) intramuscular treatment,
* Being literate,
* Are between the ages of 18-65,
* No visual, hearing, sensory or motor loss or cognitive impairment,
* Not using centrally or peripherally acting analgesics or sedatives,
* There is no scar tissue, incision, lipodystrophy or signs of infection on the skin of the injection area,
* Having a body mass index between 18.5 and 29.5,
* Injected into the ventrogluteal area,
* Individuals who agree to participate in the research will be included.

Exclusion Criteria:

* Those with chronic pain,
* Having a psychiatric disorder,
* Foreign nationals,
* Patients with contact-communicable diseases will be excluded from the study.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ssu@erbakan.edu.tr

**Name:** Serpil SU

**Phone:** 05052611380

**Role:** CONTACT

**Contact 2:**

**Email:** m1kk.akblt@gmail.com

**Name:** Melike AKBULUT

**Phone:** 05392822149

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Necmettin Erbakan University

**Name:** Serpil SU

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Misc Info Module

- Version Holder: 2024-05-31
