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

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

Official Title
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Effectiveness of the Application of a Nursing Intervention Program in the Management of Parental Anxiety and Infant Pain in the Surgical Process of Children to be Circumcised

Conditions
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Anxiety, Pain, Postoperative, Child Development

Intervention / Treatment
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* Behavioral: Intervention group
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 0-3 years who are going to undergo circumcision and the relatives/guardians. Exclusion Criteria: Children with micropenis

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly assigned to one group (intervention) or the other (control).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nursing Intervention<br>The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians. | Behavioral: Intervention group<br>* The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.<br>|
| Other: Usual intervention<br>The control group will receive the usual intervention of the center. | Behavioral: Control group<br>* The control group will receive the usual intervention of the center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative telephone follow-up | Postoperative telephone follow-up will be carried out to assess aspects related to the clinical evolution of the surrounded child and the resolution of any doubts that the caregivers may have. | Days 2 and 10 after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Child Preschool, Circumcision Male, Pain