Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07455266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Postoperative Holistic Nursing Care on Children's Satisfaction and Nursing Image Perception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study because the intervention (mandala coloring accompanied by music) cannot be blinded to participants or care providers.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in a 1:1 ratio to either the intervention group (holistic nursing care including mandala coloring with music) or the control group (routine postoperative nursing care).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Satisfaction with Nursing Care", 'timeFrame': 'During postoperative hospitalization (prior to discharge, approximately 1-3 days after surgery)', 'description': "Satisfaction scores measured using the Pediatric Surgery Patient Satisfaction Scale administered during the postoperative hospitalization period prior to discharge.\n\nChildren's satisfaction with nursing care will be assessed using the Pediatric Surgery Patient Satisfaction Scale developed by Ünal et al. (2023). In this study, the Postoperative Care subdimension of the scale will be used. This subdimension consists of 5 items rated on a 5-point Likert scale ranging from 1 (never) to 5 (always).\n\nTotal scores range from 5 to 25, with higher scores indicating higher satisfaction with nursing care."}, {'measure': 'Perceived Nursing Image Score', 'timeFrame': 'During postoperative hospitalization (prior to discharge, approximately 1-3 days after surgery)', 'description': "Perceived nursing image scores measured using the Children's Perceived Nursing Image Scale during the postoperative hospitalization period prior to discharge.\n\nChildren's perceptions of nursing will be assessed using the Children's Perceived Nursing Image Scale, developed by Apaydın Cırık et al. (2025). The scale evaluates children's perceptions of nurses' professional roles, communication, caregiving behaviors, and nurse-child interactions.\n\nItems are rated on a Likert-type scale, and the total score is calculated by summing item scores. Higher scores indicate a more positive perception of the nursing image."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Holistic Nursing Care', 'Pediatric Surgery', 'Mandala Coloring', 'Music Intervention', 'Patient Satisfaction', 'Nursing Image', 'Randomized Controlled Trial', 'Non-Pharmacological Intervention'], 'conditions': ['Pediatric Surgical Patients', 'Postoperative Care']}, 'descriptionModule': {'briefSummary': "This randomized controlled study aims to evaluate the effect of holistic nursing care applied during the postoperative period on children's satisfaction with care and their perception of nursing image. The study will be conducted in the Pediatric Surgery Clinic of Antalya Training and Research Hospital with children aged 8 to 11 years who undergo surgical procedures.\n\nParticipants will be randomly assigned to either an intervention group or a control group. All children will receive routine postoperative nursing care. In addition to routine care, children in the intervention group will participate in a mandala coloring activity accompanied by music. This supportive activity is designed to help children relax, express their feelings, and improve their hospital experience.\n\nData will be collected using standardized questionnaires that measure children's satisfaction with nursing care and their perception of nurses. The study aims to determine whether holistic nursing practices can improve children's satisfaction and positively influence how they perceive the nursing profession.", 'detailedDescription': "This study is designed as a single-center, parallel-group, randomized controlled trial to evaluate the effect of postoperative holistic nursing care on children's satisfaction with care and their perception of nursing image. The study will be conducted in the Pediatric Surgery Clinic of Antalya Training and Research Hospital.\n\nThe target population consists of children aged 8-11 years who are hospitalized for surgical procedures. A total of 70 participants will be recruited and randomly assigned to either the intervention group (n=35) or the control group (n=35). Randomization will be performed using an appropriate random allocation method to ensure equal distribution between groups.\n\nAll participants will receive routine postoperative nursing care according to institutional standards. In addition to routine care, children in the intervention group will receive a structured holistic nursing intervention consisting of mandala coloring accompanied by music during the postoperative period. This intervention is designed to promote emotional expression, relaxation, and active participation in the care process. The activity will be implemented in a safe and supervised clinical environment.\n\nData will be collected using the Child Information Form, the Pediatric Surgery Patient Satisfaction Scale, and the Perceived Nursing Image Scale for Children. These instruments are validated tools used to assess satisfaction with nursing care and children's perception of the nursing profession. Outcome measurements will be obtained during the postoperative hospitalization period prior to discharge.\n\nThe primary outcomes of the study are (1) children's satisfaction with nursing care and (2) perceived nursing image scores. The study hypothesizes that children who receive holistic nursing care will report higher satisfaction levels and more positive perceptions of nursing compared to the control group.\n\nThis research aims to contribute to evidence-based pediatric surgical nursing practice by evaluating the effectiveness of holistic, non-pharmacological supportive care interventions in improving children's hospital experiences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 8 to 11 years\n* Hospitalized in the pediatric surgery clinic\n* Undergoing a surgical procedure\n* In the postoperative period during hospitalization\n* Able to communicate verbally\n* Parent/guardian consent and child assent obtained\n\nExclusion Criteria:\n\n* Cognitive impairment preventing completion of questionnaires\n* Hearing impairment preventing participation in music intervention\n* Severe postoperative complications requiring intensive care\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT07455266', 'briefTitle': "Effect of Postoperative Holistic Nursing Care on Children's Satisfaction and Nursing Image Perception", 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': "Effect of Postoperative Holistic Nursing Care on Children's Satisfaction and Perception of the Nursing Profession: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'TBAEK-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Holistic Nursing Care Group', 'description': 'Participants in this group will receive routine postoperative nursing care in addition to a structured holistic nursing intervention consisting of mandala coloring accompanied by music during the postoperative period.', 'interventionNames': ['Behavioral: Mandala Coloring with Music']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Nursing Care Group', 'description': 'Participants in this group will receive routine postoperative nursing care according to institutional standards without additional holistic intervention.', 'interventionNames': ['Other: Routine Postoperative Nursing Care']}], 'interventions': [{'name': 'Mandala Coloring with Music', 'type': 'BEHAVIORAL', 'description': 'A structured holistic nursing intervention consisting of mandala coloring accompanied by music implemented during the postoperative hospitalization period.', 'armGroupLabels': ['Holistic Nursing Care Group']}, {'name': 'Routine Postoperative Nursing Care', 'type': 'OTHER', 'description': 'Standard postoperative nursing care provided in the pediatric surgery clinic according to institutional protocols.', 'armGroupLabels': ['Routine Nursing Care Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ayla Kaya, RN, PhD', 'role': 'CONTACT', 'email': 'aylakaya@akdeniz.edu.tr', 'phone': '+90 242 310 6103'}, {'name': 'Semra Erol, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Antalya Training and Research Hospital - Pediatric Surgery Clinic', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'centralContacts': [{'name': 'Ayla Kaya, RN, PhD', 'role': 'CONTACT', 'email': 'aylakaya@akdeniz.edu.tr', 'phone': '+90 242 310 6103'}], 'overallOfficials': [{'name': 'Semra Erol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akdeniz University Faculty of Nursing'}, {'name': 'Ayla Kaya', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akdeniz University Faculty of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ayla Kaya', 'investigatorAffiliation': 'Akdeniz University'}}}}