NCT06756529

Brief Summary

This study was conducted to determine the effect of hand massage on postoperative anxiety, pain, fear, and nausea and vomiting after pediatric surgery. This is a randomized, controlled experimental study. The sample consisted of 107 sick children who underwent ingunial hernia surgery (control: 55; experimental: 52). Hand massage was applied to the sick children in the experimental group the day before the surgery, on the morning of the surgery and after the surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

December 24, 2024

Last Update Submit

January 2, 2025

Conditions

Keywords

hand massagepainanxietyfearnausea-vomitingchildnurse

Outcome Measures

Primary Outcomes (12)

  • State-Trait Anxiety Scale

    This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety. If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given. The total score obtained from each scale is between 20-80.

    one day before surgery

  • State-Trait Anxiety Scale

    This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety. If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given. The total score obtained from each scale is between 20-80.

    the morning of surgery

  • State-Trait Anxiety Scale

    This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety. If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given. The total score obtained from each scale is between 20-80.

    1st day after surgery

  • Wong Baker Pain Rating Scale

    It contains a total of 6 facial expressions. Scoring is made between zero and five. "I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score. With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.

    one day before surgery

  • Wong Baker Pain Rating Scale

    It contains a total of 6 facial expressions. Scoring is made between zero and five. "I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score. With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.

    the morning of surgery

  • Wong Baker Pain Rating Scale

    It contains a total of 6 facial expressions. Scoring is made between zero and five. "I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score. With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.

    1st day after surgery

  • Medical Fear Scale

    This scale is a three-choice Likert type scale. For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated. The lowest score on the scale is 27 and the highest score is 87. Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.

    one day before surgery

  • Medical Fear Scale

    This scale is a three-choice Likert type scale. For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated. The lowest score on the scale is 27 and the highest score is 87. Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.

    the morning of surgery

  • Medical Fear Scale

    This scale is a three-choice Likert type scale. For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated. The lowest score on the scale is 27 and the highest score is 87. Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.

    1st day after surgery

  • Baxter Nausea Facial Expressions Scale (BARF Scale)

    This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.

    one day before surgery

  • Baxter Nausea Facial Expressions Scale (BARF Scale)

    This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.

    the morning of surgery

  • Baxter Nausea Facial Expressions Scale (BARF Scale)

    This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.

    1st day after surgery

Study Arms (2)

experimental group

EXPERIMENTAL

group receiving hand massage

Other: hand massage

control group

NO INTERVENTION

Group without hand massage

Interventions

Hand massage was applied to the patients before surgery, on the morning of surgery and after surgery.

Also known as: experimental group
experimental group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Are between the ages of 7-12,
  • Pediatric patients who are scheduled for ingunial hernia surgery,
  • Volunteers to participate in the research,
  • Those whose families agree to participate in the research
  • No communication problems (vision, hearing, mental),
  • For patients in the experimental group; All patients who did not have an infectious disease on the hand skin (shingles, fungus, eczema, warts, calluses), local infection (abscess, etc.), open lesion/wound, scar tissue, edema, hematoma, recent fracture or dislocation were included in the sample.

You may not qualify if:

  • Being outside the 7-12 age range,
  • Pediatric patients for whom ingunial hernia surgery is not planned,
  • Those who do not volunteer to participate in the research,
  • The family does not agree to participate in the research
  • Having communication problems
  • For patients in the experimental group, patients with infectious diseases, lesions, open wounds, hematomas, fractures-dislocations on the skin of the hands were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Palandöken, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 3, 2025

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

January 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations