- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05324527
The Effect of Preoperational Hand Massage Anxiety Level And Hemodynamic Variables
April 5, 2022 updated by: Didem Lafci, Mersin University
The Effect of Preoperational Hand Massage Applied to Children on Anxiety Level And Hemodynamic Variables: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mersin, Turkey, 33110
- Mersin University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum.
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No Intervention: Control group
The control group will be received routine treatment and care in the unit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety evaluated using the State Anxiety Scale
Time Frame: Change from before implementation and after 16 minutes of practice (hand massage)
|
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
|
Change from before implementation and after 16 minutes of practice (hand massage)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Change from before implementation and after 16 minutes of practice (hand massage)
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systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg
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Change from before implementation and after 16 minutes of practice (hand massage)
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Heart rate
Time Frame: Change from before implementation and after 16 minutes of practice (hand massage)
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beats per minute
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Change from before implementation and after 16 minutes of practice (hand massage)
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respiratory rate
Time Frame: Change from before implementation and after 16 minutes of practice (hand massage)
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ekspiration and inspiration per minute
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Change from before implementation and after 16 minutes of practice (hand massage)
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peripheral oxygen saturation
Time Frame: Change from before implementation and after 16 minutes of practice (hand massage)
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%, percentage of oxygenated hemoglobin in peripheral arterial blood
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Change from before implementation and after 16 minutes of practice (hand massage)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fahri AŞKAN, Master, 100. Year University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
March 25, 2022
First Submitted That Met QC Criteria
April 5, 2022
First Posted (Actual)
April 12, 2022
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 5, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MersinUniv
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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