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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.
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 PoliclÃnica 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 ClÃnica amb Medicaments de l'Hospital de Mataró with code CEIm 03/22.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nursing Intervention | Experimental | The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians. |
|
| Usual intervention | Other | The control group will receive the usual intervention of the center. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | Behavioral | The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PoliclÃnica Maresme | Pineda de Mar | Barcelona | 08397 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41978788 | Derived | Andrusenko-Kalchenko L, Romero-Collado A, Ballester-Ferrando D, Sanvicens A, Zabaleta-Del-Olmo E, Rascon-Hernan C. Nurse-Led Intervention to Reduce Parental Anxiety and Child Pain During Non-Therapeutic Male Circumcision: A Randomized Trial. SAGE Open Nurs. 2026 Apr 10;12:23779608261442615. doi: 10.1177/23779608261442615. eCollection 2026 Jan-Dec. |
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The data will only be used by the study investigators.
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Subjects will be randomly assigned to one group (intervention) or the other (control).
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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).
| Control group | Behavioral | The control group will receive the usual intervention of the center. |
|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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