The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters in Babies

NCT05752747 | Completed

• 1 other identifier: KAEK 07
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.

Conditions

Vaccine; Pain

Outcome Measures

Primary Outcomes (10)

• crying

  crying time

  1 minute before the procedure

• crying

  crying time will be measured and noted.

  1 minute after the procedure

• SpO2

  Physiological parameters

  1 minute before the procedure

• SpO2

  Physiological parameters

  1 minute after the procedure

• Pulse

  Physiological parameters

  1 minute before the procedure

• Pulse

  Physiological parameters

  1 minute after the procedure

• Body temperature

  Physiological parameters

  1 minute before the procedure

• Body temperature

  Physiological parameters

  1 minute after the procedure

• FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)

  The FLACC scale was first developed by Merkel et al.in 1997. In the research, it will be used to evaluate the pain levels of infants in the experimental and control groups before, during and after vaccination. The five behaviors ("face", "legs", "activity", "crying" and "consolation") evaluated on this scale are considered indicators of pain that can be detected and graded by an observer. Descriptors for each item are accepted as indicators of children's painful behavior. Each item is scored from 0 to two, resulting in a pain intensity score ranging from 0 to 10. And descriptors associated with each score level represent pain intensity.

  1 minute before the procedure

• FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)

  The FLACC scale was first developed by Merkel et al.in 1997. In the research, it will be used to evaluate the pain levels of infants in the experimental and control groups before, during and after vaccination. The five behaviors ("face", "legs", "activity", "crying" and "consolation") evaluated on this scale are considered indicators of pain that can be detected and graded by an observer. Descriptors for each item are accepted as indicators of children's painful behavior. Each item is scored from 0 to two, resulting in a pain intensity score ranging from 0 to 10. And descriptors associated with each score level represent pain intensity.

  1 minute after the procedure

Study Arms (3)

Cold Massage Group

EXPERIMENTAL

Just before the application, it will be taken out of the cabinet and the area to be vaccinated will be massaged with rollers with back and forth movements.

Other: Cold Massage Group

ShotBlocker© Group

EXPERIMENTAL

It is a small flexible drug-free plastic tool. It is a small, flat-shaped instrument with a short, blunt, skin-contact ridge on the bottom and a hole in the center to inject. It is placed on the skin before injection. The protrusions on the inside do not harm the skin.

Other: ShotBlocker© Group

Control Group

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

Cold Massage Group OTHER

Just before the application, it will be taken out of the cabinet and the area to be vaccinated will be massaged with rollers with back and forth movements.

Cold Massage Group

ShotBlocker© Group OTHER

It is a small flexible drug-free plastic tool. It is a small, flat-shaped instrument with a short, blunt, skin-contact ridge on the bottom and a hole in the center to inject. It is placed on the skin before injection. The protrusions on the inside do not harm the skin.

ShotBlocker© Group

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The baby is 2-6 months old,
• DaBT- IPA- Hib vaccine will be administered,
• The baby does not have a chronic disease,
• Parents must be at least primary school graduate,
• Parent's willingness to participate in the study.

You may not qualify if:

• Having a congenital or neurological health problem,
• Have taken an analgesic drug in the last 4 hours,
• Babies with a body temperature above 37.5 will not be included in the study.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Dilek alemdar

Ordu, 52000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Küçük Alemdar

  Assoc. Dr.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In order to prevent selection bias, the assignment of infants to groups will be made using "stratification and randomization methods with blocks". Parents will not be informed which group their baby is in (ShotBlocker©, cold massage, control). In the study, the pain level of the infants will be evaluated by the family health worker, the researcher and their parents who administered the vaccine. At the end of the study, inter-observer agreement will be evaluated. Parents and family health workers will be informed by the researcher about the pain scale to be used in the research. In addition, the database of the research will be created by a university graduate statistician working in a statistical center independent of the research, apart from the researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This study was planned as randomized controlled experimental.

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: November 22, 2022
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)