The Effect of Preoperational Hand Massage Anxiety Level And Hemodynamic Variables

NCT ID: NCT05324527

Last Updated: 2022-04-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-09-01

Brief Summary

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The study was conducted randomly controlled experimental to determine the effect of hand massage applied to pre-operative children on anxiety level and physical symptoms of anxiety.

Detailed Description

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On operation morning, "Child and Parent Introduction Form", "State-Trait Anxiety Inventory for Children" were read to and "Physiological Symptoms of Anxiety Inspection Form" measurement was done on children in both groups, and their 1st measurement values were recorded. Routine treatment and nursing care applications of the service were done preoperationally. After the researcher and the children in study group sat on a chair facing each other, hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum. No massage was applied to children in control group. Right 16 minutes after the 1st filled forms in each group, "State-Trait Anxiety Inventory for Children", "Physiological Symptoms of Anxiety Inspection Form" were read, measurement was done and 2nd measurement values were recorded. Furthermore, "Satisfaction Evaluation Scale" was marked by those in study group after the massage, and measurement values were recorded.

Conditions

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Anxiety Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, two-arm, randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Masking Description According to the randomization table, the information showing the patients included in the research sample is assigned to the A and B groups will be put in an opaque envelope. This envelope will be kept by the coordinator researcher (DL) and when the researcher (FA) goes to the patient for application, after filling out the "Informed Voluntary Consent Form", he will open the envelope and learn which group is in which group. Due to the nature of the study, patients and the researcher (FA) will notbe blinded, since abdominal massage will be applied only to the patients included in the study. When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups, and the data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will be blind to group assignment

Study Groups

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Hand Massage Group

After the researcher and the children in study group sat on a chair facing each other, hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum.

Group Type EXPERIMENTAL

Hand Massage

Intervention Type OTHER

Hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum.

Control group

The control group will be received routine treatment and care in the unit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hand Massage

Hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Agreeing to participate in the study and obtaining written permission from the family,
* Able to speak and understand Turkish,
* Not taking any analgesic and anesthetic drugs before the procedure,
* Over 9 years old and under 12 years old,
* whose parents are literate,
* Poor general condition and not needing emergency surgery (cases such as acute abdomen, intestinal perforations, traumas, etc.),
* There is no open wound on the skin or an obstacle to massage (edema, abscess, skin infection with necrosis, etc.),
* Thrombophlebitis, occlusive artery disease, fever etc. who do not have a situation in which massage application is objectionable due to illness, He does not have conditions such as loss of sensation, mass, fracture and ingrown nails in his hand,
* Children who are conscious, fully oriented and cooperative and open to communication

Exclusion Criteria

* Those who do not accept to participate in the research and do not get written permission from their families,
* Does not speak or understand Turkish
* Taking any analgesic and anesthetic drugs before the procedure,
* Less than 9 years old and over 12 years old,
* illiterate parents
* Poor general condition and emergency surgery (acute abdomen, intestinal perforations, traumas, etc.) cases) need,
* Open wound on the skin or an obstacle to massage (edema, abscess, necrosis has occurred) skin infection etc.)
* Thrombophlebitis, occlusive artery disease, fever etc. massage practice due to illness having a situation where it is objectionable,
* Having conditions such as loss of sensation in the hand, mass, fracture and ingrown nails,
* Children who are unconscious, oriented and cooperative and not open to communication
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Didem Lafci

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fahri AŞKAN, Master

Role: PRINCIPAL_INVESTIGATOR

100. Year University

Locations

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Mersin University

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MersinUniv

Identifier Type: -

Identifier Source: org_study_id

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