Clinical trial NCT05324527: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Hemodynamic Instability
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 84
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two-arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Anxiety evaluated using the State Anxiety Scale
timeFrame: Change from before implementation and after 16 minutes of practice (hand massage)
Secondary outcomes:
measure: Blood pressure
timeFrame: Change from before implementation and after 16 minutes of practice (hand massage)
measure: Heart rate
timeFrame: Change from before implementation and after 16 minutes of practice (hand massage)
measure: respiratory rate
timeFrame: Change from before implementation and after 16 minutes of practice (hand massage)
measure: peripheral oxygen saturation
timeFrame: Change from before implementation and after 16 minutes of practice (hand massage)
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: 100. Year University
name: Fahri AŞKAN, Master
role: PRINCIPAL_INVESTIGATOR
References: