Male Circumcision and Comfort Theory

NCT ID: NCT04105556

Last Updated: 2019-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-03-01

Brief Summary

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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

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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.

Conditions

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Nursing Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
Male child and care provider

Study Groups

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Nursing Care Based on Kolcaba's Comfort Theory

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.

Group Type EXPERIMENTAL

Nursing Care Based on Kolcaba's Comfort Theory

Intervention Type OTHER

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

Routine hospital schedule

The researcher sincerely answered all questions asked by the control group during the perioperative period.

After the post-discharge post-tests, the control group was given a gift of medal of courage, a story book and a training booklet prepared for the parents after the policlinic control on the 10th postoperative day, and the training was given to the intervention group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nursing Care Based on Kolcaba's Comfort Theory

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

Intervention Type OTHER

Other Intervention Names

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• Pre-surgical preparation program • Comfort-oriented care • Tele-monitoring and consultancy

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

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Fahriye Celik

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine EFE

Role: STUDY_DIRECTOR

Akdeniz Universty

Locations

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Fahriye PAZARCIKCI

Isparta, Türki̇ye, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fahriye PAZARCIKCI, Res. Assist.

Role: CONTACT

05052560327 ext. 05052560327

Emine EFE, Professor

Role: CONTACT

02422496295

Facility Contacts

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Fahriye PAZARCIKCI

Role: primary

05052560327 ext. 05052560327

References

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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.

Reference Type BACKGROUND
PMID: 17004666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17627198 (View on PubMed)

Dowd T, Kolcaba K. Two interventions to relieve stress in college students. Beginnings. 2007 Winter;27(1):10-1. No abstract available.

Reference Type BACKGROUND
PMID: 17381027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17099440 (View on PubMed)

Kolcaba K, DiMarco MA. Comfort Theory and its application to pediatric nursing. Pediatr Nurs. 2005 May-Jun;31(3):187-94.

Reference Type RESULT
PMID: 16060582 (View on PubMed)

Other Identifiers

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SuleymanDUnursingcare

Identifier Type: -

Identifier Source: org_study_id

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