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The Effect of Preoperational Hand Massage Anxiety Level And Hemodynamic Variables

Primary Purpose

Anxiety, Hemodynamic Instability

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Hand Massage

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mersin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hand Massage Group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Anxiety evaluated using the State Anxiety Scale

Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also hig

Secondary Outcome Measures

Blood pressure

systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg

Heart rate

beats per minute

respiratory rate

ekspiration and inspiration per minute

peripheral oxygen saturation

%, percentage of oxygenated hemoglobin in peripheral arterial blood

Full Information

NCT ID

NCT05324527

First Posted

March 25, 2022

Last Updated

April 5, 2022

Sponsor

Mersin University

1. Study Identification

Unique Protocol Identification Number

NCT05324527

Brief Title

The Effect of Preoperational Hand Massage Anxiety Level And Hemodynamic Variables

Official Title

The Effect of Preoperational Hand Massage Applied to Children on Anxiety Level And Hemodynamic Variables: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

September 1, 2017 (Actual)

Study Completion Date

September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Hemodynamic Instability

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective, parallel, two-arm, randomized controlled clinical trial

Masking

Participant

Masking Description

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

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hand Massage Group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Hand Massage

Intervention Description

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

Primary Outcome Measure Information:

Title

Anxiety evaluated using the State Anxiety Scale

Description

Time Frame

Change from before implementation and after 16 minutes of practice (hand massage)

Secondary Outcome Measure Information:

Title

Blood pressure

Description

systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg

Time Frame

Change from before implementation and after 16 minutes of practice (hand massage)

Title

Heart rate

Description

beats per minute

Time Frame

Change from before implementation and after 16 minutes of practice (hand massage)

Title

respiratory rate

Description

ekspiration and inspiration per minute

Time Frame

Change from before implementation and after 16 minutes of practice (hand massage)

Title

peripheral oxygen saturation

Description

%, percentage of oxygenated hemoglobin in peripheral arterial blood

Time Frame

Change from before implementation and after 16 minutes of practice (hand massage)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fahri AŞKAN, Master

Organizational Affiliation

100. Year University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mersin University

City

Mersin

ZIP/Postal Code

33110

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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The Effect of Preoperational Hand Massage Anxiety Level And Hemodynamic Variables

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