NCT07157501

Brief Summary

The study's aim is to examine the effect of using aromatherapy versus acupressure on pain intensity and sleep pattern for children undergoing abdominal surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 23, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

ChildrenPainSleep patternAromatherapyAccupressureAbdominal surgeries

Outcome Measures

Primary Outcomes (2)

  • Change in pain intensity as measured by the Word-Graphic Rating Scale (WGRS)

    Pain intensity will be assessed using the Word-Graphic Rating Scale (WGRS), a validated self-report scale for children aged 6-12 years. The scale includes descriptive words along a line, ranging from "No pain" to "Worst possible pain." Children point to the word that best describes their pain level. Scores range from 0 to 10, with higher scores indicating greater pain intensity. The change from baseline to post-intervention will be analyzed. Unit of Measure: Score on a 0-10 scale

    Baseline (pre-intervention), and 30 minutes post-intervention

  • Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)

    Pittsburgh Sleep Quality Index: It is a self-report questionnaire that assessed sleep quality and sleep pattern. The scale consists of components such as subjective sleep quality, sleep latency, habitual sleep efficiency, sleep disturbance, day time dysfunction. This rating scale consists of 30 items based on the 5 components. The scale will be used for the pre and post-test. Scoring of answer is based on 4-point rating scale (0 -3). Never - 0, Occasionally - 1, Frequently - 2, Always - 3. Scoring system : Good quality of sleep 0-30. Fair quality of sleep 31-60. Poor quality of sleep61-90

    Baseline (pre-intervention) and at the morning of 2nd postoperative day and at the morning of 3rd postoperative day

Study Arms (2)

Using aromatherapy for pain and sleep disturbance

EXPERIMENTAL

participants in this group received aromatherapy only for decreasing pain intensity and improving sleep quality for children after abdominal surgeries

Other: Aromatherapy inhaler

Acupressure for pain and sleep disturbances for children after abdominal surgery

EXPERIMENTAL

participants in this group received acupressure for decreasing pain and improving sleep quality after abdominal surgery

Behavioral: Accupressure

Interventions

AccupressureBEHAVIORAL

Acupressure will be applied by pressing in circular movements on the acupoint with the thumb finger first in clock wise and then anti-clock wise direction. The finger must remain at the same point on the skin and be moved in small circles

Acupressure for pain and sleep disturbances for children after abdominal surgery

The lavender inhalation application will be explained to the children and their mothers. Two drops of 100% pure organic lavender oil will poured on a cotton. The cotton will have fixed by the child at 5 cm distance from his or her nose and will asked to breathe slowly for 10-15 minutes

Using aromatherapy for pain and sleep disturbance

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children age 6 to 12 years of both sexes. Conscious and having a caretaker. No history of respiratory diseases or has problems with his sense of smell (for aromatherapy group).
  • Children undergoing abdominal surgeries such as acute appendicitis, intestinal obstruction, Inguinal and umbilical hernia

You may not qualify if:

  • Post-operative severe pain preventing children from participating in the study. Children who have chronic disease such as cardiac and renal disease. The existence of coagulation disorders, as well as skin diseases or skin burns in the pressure points where in acupressure could be applied (for acupressure group).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of nursing - Mansoura university

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

AppendicitisHerniaPain

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Asmaa S.A. El Malah, PhD

    Faculty of Nursing, Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 23, 2025

First Posted

September 5, 2025

Study Start

April 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 30, 2024

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations