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

NCT ID: NCT05387291

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-05-22

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.

Detailed Description

1. Introduction 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.

2. Hypothesis / problem A nursing intervention program in the surgical process of circumcision decreases the degree of anxiety of family members and reduces infant pain.

3. Methodology A randomized clinical trial will be carried out at the Policlínica Maresme, located in Pineda de Mar, on the relatives/guardians and children aged 0-3 years who are going to undergo circumcision.

The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians. The control group will receive the usual intervention of the center. It has been estimated that 157 subjects are needed in each group, estimating a loss to follow-up of 10%.

Among other variables, the preoperative anxiety level of the parents will be measured using the Hamilton scale; intraoperatively, child pain will be measured using the FLACC scale and, subsequently, a postoperative telephone follow-up will be carried out during the 2 and 10 days following the intervention, to assess aspects related to the clinical evolution of the surrounded child and the resolution of any doubts that the caregivers may have.

The confidentiality of the study participants will be guaranteed. The research project has been approved by the Comité d'Ètica d'Investigació Clínica amb Medicaments de l'Hospital de Mataró with code CEIm 03/22.

Conditions

Anxiety; Pain, Postoperative; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nursing Intervention

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

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: BEHAVIORAL

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

Usual intervention

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

Group Type: OTHER

Control group

Intervention Type: BEHAVIORAL

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

Interventions

Intervention group

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

Intervention Type: BEHAVIORAL

Control group

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Children with micropenis

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat de Girona

OTHER

Sponsor Role: lead

Responsible Party

Lyudmila Andrusenko Kalchenko

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlínica Maresme

Pineda de Mar, Barcelona, Spain

Countries

Spain

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id