AppendicitisNCT07157501
Aromatherapy Versus Acupressure: Impact on Postoperative Pain and Sleep Quality in Pediatric Abdominal Surgery Patients
A study testing Accupressure and Aromatherapy inhaler in people with Appendicitis and Hernia, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Appendicitis, Hernia, Abdominal Exploration
- What is being tested?
- Accupressure and Aromatherapy inhaler
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Using Aromatherapy Versus Acupressure on Pain Intensity and Sleep Pattern for Children Undergoing Abdominal Surgeries
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.
Read the detailed description
Abdominal surgery is defined as a broad term used for various surgical procedures around the abdominal region. These can be used to treat or diagnose medical conditions present in that area. The surgery can be performed on multiple sites like the small intestines, spleen, stomach, appendix, and rectum or colon . Abdominal surgery in children can involve various techniques that depend on the organs which require an operation, that divided into two types; laparotomy and laparoscopic surgeries .
Laparotomies are defined as major surgeries which need large incisions on the abdomen of the child. These procedures require close, carful management to avoid it's major complications that extend the time of recovery. On the other hand, laparoscopic surgeries are smaller incisions made significantly than Laparotomies, that make little scars, less blood loss, decreased pain after surgery, and faster recovery . The most common cases of laparotomies among pediatric patients are adhesive bowel obstruction, adhesiolysis, open reduction of intussusception and bowel resection. While the procedures of laparoscopic surgeries that are used in pediatric patients are appendectomy, cholecystectomy, liver biopsy, ovarian distortion and orchidopexy. Pain is the serious postoperative problem that may result from operations due to tissue damage caused by surgical incisions that occurs shortly after surgery. It leads to the production of cellular breakdown and inflammatory mediators which trigger the nerve ending and send messages through the dorsal horn to the brain. The end effect of this pain transmission neuronal activity is pain perception. More than 80% of children who undergo surgical procedures experience acute postoperative pain. About 30-43% of pediatric patients report moderate or severe pain on the first postoperative day . The next most prevalent post-operative problem is insomnia. Hospitalized children frequently experience sleep disorders for many reasons such as physical condition, medications, fear of death, light, environmental noise, unpleasant odors, foreign instruments, nursing interventions, invasive procedures, complications of disease, loss of privacy and staying away from family. About 40-60% of hospitalized children have sleep disturbance . The hospitalized children stay awake for a significant amount of time; they cannot benefit from the therapeutic effects of sleep. Inadequate and unsatisfactory sleep impedes healing process by having negative effects on the immune system, wound healing process, cause fatigue, anorexia, muscle atrophy, delayed recovery, affect cognitive functions of children and increasing their level of stress and anxiety as well as, impair children's mental and physical development by directly affecting protein synthesis, cell differentiation, and growth hormone secretion .
Postoperative pain and insomnia are associated with increased morbidity and dysfunction that can delay time to ambulation and prolong the hospital length of stay. When postsurgical pain and insomnia are not appropriately managed, they may develop into chronic postoperative pain and fatigue, which, in turn, may lead to dysfunction, disability, and depression, and be difficult to manage.
Pediatric nurses play an important role in managing postoperative pain and insomnia among pediatric patients. They spend most of their time with the child and are accountable for assessment, the administration of analgesics, monitoring and reporting the outcomes of the given treatments. Some nurses believe that pain and insomnia are expected outcomes of surgery, hence, there is no need to alleviate the postoperative pain and insomnia completely .
The use of Complementary Alternative Medicine (CAM) in pediatric populations is considerably increased, especially for pain, sleep disturbance and acute conditions. The main reasons for seeking CAM were: the wish of avoiding chronic use of drugs with their related side effects, the desire of an integrated approach, the reported inefficacy of conventional medicine, and a more suitable children disposition to CAM than to pharmacological compound .
Aromatherapy is considering one type of CAM. Aromatherapy refers to the therapeutic use of essential oils absorbed through the skin or olfactory system. It's used for controlling the pain, anxiety, depression, stress, and improves the sleep pattern among pediatric patients. The benefits of lavender's aromatherapy that linalool and linalyl acetate present in this plant can stimulate parasympathetic system. In addition, linalyl acetate has narcotic effects and linalool acts as a sedative. This herb improves the heart function and as a circulatory stimulant, it has beneficial effects on coronary blood flow.
Another type of CAM is acupressure, it's a non-invasive form of traditional Chinese Medicine that is common throughout Chinese society as a method of promoting health. It includes applying of pressure manually to certain points on the body through energy pathways called meridians which spread energy in the body and connect the body parts with its organs. Appling acupressure technique can be done by using the fingertips or wristband to relieve post-operative pain and improve quality of sleep . Pain and sleep disorders are treated using both pharmacological and non-pharmacological methods. Sedative-hypnotic agents used in pharmacological treatments can reduce pain and increase the quality of sleep significantly; however, it is stated that these drugs have side effects, cause addiction and do not provide adequate sleep . Therefore, it is essential to employ and implement non-pharmacological methods that are safer and have fewer side effects than the pharmacological methods.
- Conditions
- Appendicitis, Hernia, Abdominal Exploration, Splenectomy
- Being tested
- Accupressure, Aromatherapy inhaler
- Keywords
- Children, Pain, Sleep pattern, Aromatherapy, Accupressure, Abdominal surgeries
- Medical subject headings
- Appendicitis, Hernia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccupressureBehavioural
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
Aromatherapy inhalerOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Accupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline (pre-intervention) and at the morning of 2nd postoperative day and at the morning of 3rd postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Apr 2024
- Primary completion1 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Sabry Attia Hassan El malah, Mansoura University
- Investigators
- Asmaa S.A. El Malah, PhD, Principal investigator, Faculty of Nursing, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157501
- Sponsor's protocol ID
- CAT for pain and sleep pattern
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Aromatherapy Versus Acupressure on Pain Intensity and Sleep Pattern for Children Undergoing Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT07157501
- Acronym / sponsor ID
- CAT for pain and sleep pattern
- Conditions
- Appendicitis, Hernia, Abdominal Exploration, Splenectomy
- Keywords
- Children, Pain, Sleep pattern, Aromatherapy, Accupressure, Abdominal surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Abdominal surgery is defined as a broad term used for various surgical procedures around the abdominal region. These can be used to treat or diagnose medical conditions present in that area. The surgery can be performed on multiple sites like the small intestines, spleen, stomach, appendix, and rectum or colon . Abdominal surgery in children can involve various techniques that depend on the organs which require an operation, that divided into two types; laparotomy and laparoscopic surgeries .
Laparotomies are defined as major surgeries which need large incisions on the abdomen of the child. These procedures require close, carful management to avoid it's major complications that extend the time of recovery. On the other hand, laparoscopic surgeries are smaller incisions made significantly than Laparotomies, that make little scars, less blood loss, decreased pain after surgery, and faster recovery . The most common cases of laparotomies among pediatric patients are adhesive bowel obstruction, adhesiolysis, open reduction of intussusception and bowel resection. While the procedures of laparoscopic surgeries that are used in pediatric patients are appendectomy, cholecystectomy, liver biopsy, ovarian distortion and orchidopexy. Pain is the serious postoperative problem that may result from operations due to tissue damage caused by surgical incisions that occurs shortly after surgery. It leads to the production of cellular breakdown and inflammatory mediators which trigger the nerve ending and send messages through the dorsal horn to the brain. The end effect of this pain transmission neuronal activity is pain perception. More than 80% of children who undergo surgical procedures experience acute postoperative pain. About 30-43% of pediatric patients report moderate or severe pain on the first postoperative day . The next most prevalent post-operative problem is insomnia. Hospitalized children frequently experience sleep disorders for many reasons such as physical condition, medications, fear of death, light, environmental noise, unpleasant odors, foreign instruments, nursing interventions, invasive procedures, complications of disease, loss of privacy and staying away from family. About 40-60% of hospitalized children have sleep disturbance . The hospitalized children stay awake for a significant amount of time; they cannot benefit from the therapeutic effects of sleep. Inadequate and unsatisfactory sleep impedes healing process by having negative effects on the immune system, wound healing process, cause fatigue, anorexia, muscle atrophy, delayed recovery, affect cognitive functions of children and increasing their level of stress and anxiety as well as, impair children's mental and physical development by directly affecting protein synthesis, cell differentiation, and growth hormone secretion .
Postoperative pain and insomnia are associated with increased morbidity and dysfunction that can delay time to ambulation and prolong the hospital length of stay. When postsurgical pain and insomnia are not appropriately managed, they may develop into chronic postoperative pain and fatigue, which, in turn, may lead to dysfunction, disability, and depression, and be difficult to manage.
Pediatric nurses play an important role in managing postoperative pain and insomnia among pediatric patients. They spend most of their time with the child and are accountable for assessment, the administration of analgesics, monitoring and reporting the outcomes of the given treatments. Some nurses believe that pain and insomnia are expected outcomes of surgery, hence, there is no need to alleviate the postoperative pain and insomnia completely .
The use of Complementary Alternative Medicine (CAM) in pediatric populations is considerably increased, especially for pain, sleep disturbance and acute conditions. The main reasons for seeking CAM were: the wish of avoiding chronic use of drugs with their related side effects, the desire of an integrated approach, the reported inefficacy of conventional medicine, and a more suitable children disposition to CAM than to pharmacological compound .
Aromatherapy is considering one type of CAM. Aromatherapy refers to the therapeutic use of essential oils absorbed through the skin or olfactory system. It's used for controlling the pain, anxiety, depression, stress, and improves the sleep pattern among pediatric patients. The benefits of lavender's aromatherapy that linalool and linalyl acetate present in this plant can stimulate parasympathetic system. In addition, linalyl acetate has narcotic effects and linalool acts as a sedative. This herb improves the heart function and as a circulatory stimulant, it has beneficial effects on coronary blood flow.
Another type of CAM is acupressure, it's a non-invasive form of traditional Chinese Medicine that is common throughout Chinese society as a method of promoting health. It includes applying of pressure manually to certain points on the body through energy pathways called meridians which spread energy in the body and connect the body parts with its organs. Appling acupressure technique can be done by using the fingertips or wristband to relieve post-operative pain and improve quality of sleep . Pain and sleep disorders are treated using both pharmacological and non-pharmacological methods. Sedative-hypnotic agents used in pharmacological treatments can reduce pain and increase the quality of sleep significantly; however, it is stated that these drugs have side effects, cause addiction and do not provide adequate sleep . Therefore, it is essential to employ and implement non-pharmacological methods that are safer and have fewer side effects than the pharmacological methods.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using aromatherapy for pain and sleep disturbance | Experimental | Other: Aromatherapy inhalerparticipants in this group received aromatherapy only for decreasing pain intensity and improving sleep quality for children after abdominal surgeries |
| Acupressure for pain and sleep disturbances for children after abdominal surgery | Experimental | Behavioral: Accupressureparticipants in this group received acupressure for decreasing pain and improving sleep quality after abdominal surgery |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccupressureAcupressure 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 | Behavioural | Acupressure for pain and sleep disturbances for children after abdominal surgery |
| Aromatherapy inhalerThe 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 | Other | Using aromatherapy for pain and sleep disturbance |
Primary outcome
Change in pain intensity as measured by the Word-Graphic Rating Scale (WGRS)
Time frame: Baseline (pre-intervention), and 30 minutes post-intervention
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
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (pre-intervention) and at the morning of 2nd postoperative day and at the morning of 3rd postoperative day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa S.A. El Malah, PhD principal investigator
Faculty of Nursing, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accupressure and Aromatherapy inhaler in people with Appendicitis and Hernia, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity as measured by the Word-Graphic Rating Scale (WGRS) (time frame: Baseline (pre-intervention), and 30 minutes post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.