Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aim: This study was conducted to determine and compare the effectiveness of different non-pharmacological methods in pain management during vaccination.

Methods: This randomized experimental study with placebo and control groups was conducted with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of the infants were determined by blind assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Shotblocker in Spinal Needle Related Pain

NCT03554122

Needle Phobia Spinal Anesthesia Pain

COMPLETED NA

Intramuscular Injection-Related Pain and Fear

NCT03915704

Pain Fear

COMPLETED NA

The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children

NCT06354608

Procedural Pain

RECRUITING NA

Applying a Small Procedure Prior to Injection/Vaccination Reduces Pain Experiences in Child Patients

NCT06313788

Pediatric Pain

NOT_YET_RECRUITING NA

The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction

NCT06563648

Pain Satisfaction, Patient

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was designed as a randomized experimental study with placebo and control groups in order to compare the effects of ShotBlocker® and sucrose on pain reduction during vaccine injections.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

In the study, a multi-stage randomization method was used as follows: 1) random selection of the family health centres in the city in which the research was conducted; 2) selection of the mothers and infants to be included in the study at each centre; and 3) selection of the groups to which the participants were assigned using a computer-based block randomization method (https://www.randomizer.org). The infants, randomized via a computer system, were assigned to the ShotBlocker® group (n= 35), ShotBlocker®-placebo group (n = 35), sucrose group (n = 35), sucrose-placebo group (n = 35), or the control group (n=35).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Characteristics of newborns included

Characteristics of newborns included in the randomized controll

Group Type NO_INTERVENTION

No interventions assigned to this group

Intraclass Correlation between the NIPS Score of Parent, Nurse

Group Type EXPERIMENTAL

Comparisons of procedural pain

Intervention Type BEHAVIORAL

This randomized experimental study with placebo and control groups

Comparisons of procedural pain scores among groups

Group Type EXPERIMENTAL

Comparisons of procedural pain

Intervention Type BEHAVIORAL

This randomized experimental study with placebo and control groups

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Comparisons of procedural pain

This randomized experimental study with placebo and control groups

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Born at full term
* No infection, redness, deteriorated skin integrity, or nerve damage in the area of application
* Had not undergone any clinical injection.