The Effect of Preoperational Hand Massage Anxiety Level And Hemodynamic Variables

NCT05324527 | Completed

• 1 other identifier: MersinUniv
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

• Blood pressure

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

• Heart rate

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

• respiratory rate

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

• peripheral oxygen saturation

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

Study Arms (2)

Hand Massage Group

EXPERIMENTAL

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.

Other: Hand Massage

Control group

NO INTERVENTION

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

Interventions

Hand Massage OTHER

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

Hand Massage Group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, 33110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Fahri AŞKAN, Master

  100. Year University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Prospective, parallel, two-arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 12, 2022
• Study Start: April 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)