Clinical trial NCT04105556: Male Circumcision and Comfort Theory
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory to the Comfort and Components of the Child and Parents Who Are Planned for Male Circumcision Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nursing Caries
Keywords: Male Child
Comfort Theory
Fear
Male Circimcision
Pain
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 120
Sex: MALE
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type of intervention, testing the comfort and components of children and parents of the circumcision operation plan with Nursing Care Based on Kolcaba's Comfort Theory
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: Male circumcision is one of the oldest and most commonly performed surgical procedures in the world and in our country. Circumcision, which concerns such a large population, is a stressful, traumatic, negative experience. Impairment in comfort is a condition in which a child who is scheduled for circumcision operation often suffers. Physical, emotional, sociocultural and environmental factors contribute to the formation of this condition. Comfort Theory is a nursing model that makes it easier for the caregivers to see their problems more systematically and to plan more easily. In the literature review, no studies have been found to determine the effect of nursing care based on Kolcaba Konfors Comfort Theory to the comfort and components of the children and their parents who have undergone circumcision operation. Therefore, this study was needed. In this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents.

Method: In this study, the effect of nursing care based on Kolcaba's Comfort Theory on fear, anxiety, pain, comfort and anxiety in parents and health care satisfaction was tested in children. Care was given when the child and his / her parents applied to the outpatient clinic for anesthesia consultation on the working day before the operation, and care was continued in the day surgery unit. On the 1st and 3rd days after discharge, the researcher provided tele-monitoring and consultancy services. In addition, communication with the parents was maintained at all times as needed. Care was terminated on the 10th day after discharge. The time of the study was approximately 12-14 days for each child and his / her parents.

The sample of the study was determined as 120 boys and their parents (60 control each, 60 intervention each). In this study, standard nursing care will be applied to the control group and nursing care based on Kolcaba's Comfort Theory will be applied to the intervention group. The data will be collected with the Child and Family Descriptive, VAS, Children's State Anxiety (CSA) and Children's Fear Scale (CFS), Comfort Behavior Checklist, Spielberger State Anxiety Scale, PedsQL Health Care Satisfaction Scale.

Detailed description: In this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents.

Care was given when the child and his / her parents applied to the outpatient clinic for anesthesia consultation on the working day before the operation, and care was continued in the day surgery unit. On the 1st and 3rd days after discharge, the researcher provided tele-monitoring and consultancy services. In addition, communication with the parents was maintained at all times as needed. Care was terminated on the 10th day after discharge. The time of the study was approximately 12-14 days for each child and his / her parents.

Nursing care consists of 3 types of comfort-oriented care interventions. These interventions;

1. Standard maintenance interventions,
2. Emotional focused comfort care interventions,
3. Cognitive and functional comfort care interventions.

Eligibility criteria: Inclusion Criteria:

* The child is between the ages of 4-7
* No previous surgical experience of the child
* Lack of chronic disease, disability and developmental delay of the child
* The child or his / her parent does not have a special situation that causes difficulties in understanding and perception.
* Parent's ability to read and write in Turkish

Exclusion Criteria:

* Child / parent who does not volunteer to participate in the study
* Children who are not cared for at least two relatives during the surgical procedure

Primary outcomes:
measure: Comfort Behaviors Checklist
timeFrame: In two weeks
measure: VAS
timeFrame: In two weeks
measure: Children's Fear Scale
timeFrame: In two weeks
measure: Children's Anxiety Meter-State (CAM-S)
timeFrame: In two weeks
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: In two weeks
measure: The PedsQL (Pediatric Quality of Life InventoryTM)
timeFrame: In two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Fahriye PAZARCIKCI
state: Türki̇ye
Study officials:
affiliation: Akdeniz Universty
name: Emine EFE
role: STUDY_DIRECTOR
References:
citation: Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. doi: 10.1016/s0001-2092(06)63920-3.
citation: Dowd T, Kolcaba K, Steiner R, Fashinpaur D. Comparison of a healing touch, coaching, and a combined intervention on comfort and stress in younger college students. Holist Nurs Pract. 2007 Jul-Aug;21(4):194-202. doi: 10.1097/01.HNP.0000280931.75883.ae.
citation: Dowd T, Kolcaba K. Two interventions to relieve stress in college students. Beginnings. 2007 Winter;27(1):10-1. No abstract available.
citation: Kolcaba K, Tilton C, Drouin C. Comfort Theory: a unifying framework to enhance the practice environment. J Nurs Adm. 2006 Nov;36(11):538-44. doi: 10.1097/00005110-200611000-00010.
citation: Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94.