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

U

Universitat de Girona

Status

Completed

Conditions

Child Development
Pain, Postoperative
Anxiety

Treatments

Behavioral: Control group
Behavioral: Intervention group

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

314 patients

Sex

All

Ages

Under 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Children with micropenis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

314 participants in 2 patient groups

Nursing Intervention
Experimental group
Description:
The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.
Treatment:
Behavioral: Intervention group
Usual intervention
Other group
Description:
The control group will receive the usual intervention of the center.
Treatment:
Behavioral: Control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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