Nursing Intervention Program in the Management of Parental Anxiety and Infant Pain in the Surgical Process of Children to be Circumcised

NCT05387291 | Completed DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

Entering the hospital and waiting for surgery is a very stressful time for people. According to some studies, surgical interventions in children generate in family members concerns related to: anesthesia, fear of being harmed, penile injury, excessive pain, the death of their child, not being able to contain their own anxiety and, therefore, participants may have difficulties in assuming an active role in caring for their child . For these reasons, the investigators propose the development and implementation of an action program for the reduction of child pain and anxiety in parents in the foreign Muslim population residing in Spain.

Conditions

Anxiety; Pain, Postoperative; Child Development

Keywords

Anxiety; Child Preschool; Circumcision Male; Pain

Outcome Measures

Primary Outcomes (2)

• Preoperative anxiety level of the parents

  The preoperative anxiety level of the parents will be measured using the Hamilton scale. Minimum value 0, Maximum value 56. The higher the score, the higher the anxiety.

  Preoperative phase

• Intraoperatively Pain Child

  Child pain will be measured using the Face, Legs, Activity, Cry, Consolability scale (FLACC scale). Minimum value 0, Maximum value 10. The higher the score, the higher the pain.

  Intraoperatively Phase

Secondary Outcomes (1)

• Postoperative telephone follow-up

  Days 2 and 10 after the intervention.

Study Arms (2)

Nursing Intervention

EXPERIMENTAL

The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.

Behavioral: Intervention group

Usual intervention

OTHER

The control group will receive the usual intervention of the center.

Behavioral: Control group

Interventions

Intervention group BEHAVIORAL

The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.

Nursing Intervention

Control group BEHAVIORAL

The control group will receive the usual intervention of the center.

Usual intervention

Eligibility Criteria

• Age: 0 Months - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children aged 0-3 years who are going to undergo circumcision and the relatives/guardians.

You may not qualify if:

• Children with micropenis

Sponsors & Collaborators

• Universitat de Girona: lead

Study Sites (1)

Policlínica Maresme

Pineda de Mar, Barcelona, 08397, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The subjects do not know which group they are in, as some are given the usual intervention (control group) and others the intervention (intervention group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will be randomly assigned to one group (intervention) or the other (control).

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 24, 2022
• Study Start: February 1, 2022
• Primary Completion: March 12, 2022
• Study Completion: May 22, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)