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Completed

NCT Number: NCT05324527

The Effect of Preoperational Hand Massage Anxiety Level And Hemodynamic Variables

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.

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Key information

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University

Mersin, 33110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand massage

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Blood pressure

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

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

  2. Heart rate

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

    beats per minute

  3. respiratory rate

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

    ekspiration and inspiration per minute

  4. peripheral oxygen saturation

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

    %, percentage of oxygenated hemoglobin in peripheral arterial blood

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2022
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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