Abdominal SurgeryNCT06892782
Effect of Hot Pack Application on Gastrointestinal Motility After Abdominal Surgery
A study testing Hot Water Pack Application in people with Abdominal Surgery, run by TC Erciyes University.
Trial summary
Study Title: The Effect of Hot Water Pack Application to the Lumbar Region on Gastrointestinal Motility in Postoperative Abdominal Surgery Patients Study Type: Interventional (Randomized Controlled Trial) Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blind (Outcome… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Hot Water Pack Application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Undergoing elective surgery
- ASA I and III (American Society of Anesthesiologists physical status classification)
- In the postoperative period, pulse, blood pressure, and body temperature within normal limits
- Patients without previous gastrointestinal system surgery
Who cannot join
- Previous gastrointestinal tract surgery
- Complications in the postoperative period
- History of small bowel resection and ileostomy or colostomy
- History of inflammatory bowel diseases, emergency surgery, neoadjuvant therapy, appendectomy surgery
- Chronic opioid use
- Experiencing chronic constipation (≤ 2 bowel movements per week)
- Receiving abdominal radiotherapy
- Patients admitted to intensive care unit and patients with bleeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gülseren Maraş Baydoğan contact
About this study
Study Title:
The Effect of Hot Water Pack Application to the Lumbar Region on Gastrointestinal Motility in Postoperative Abdominal Surgery Patients
Read more
Study Type:
Interventional (Randomized Controlled Trial)
Study Design:
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blind (Outcome Assessor) Primary Purpose: Supportive Care
Condition:
Postoperative Gastrointestinal Motility in Abdominal Surgery Patients
Interventions:
Experimental: Hot Water Pack Application Intervention: Application of a hot water pack (heated to 40-42°C) to the lumbar region for 20 minutes, three times a day, in the first 48 postoperative hours.
Purpose: To evaluate its effect on gastrointestinal motility and postoperative recovery.
Control: Routine Care Intervention: Standard postoperative care without hot water pack application.
Primary Outcome Measures:
Time to First Postoperative Gas (Hours) [Time Frame: Up to 72 hours]
Time to First Postoperative Stool (Hours) [Time Frame: Up to 72 hours] Time to Initiation of Oral Intake (Hours) [Time Frame: Up to 72 hours]
Secondary Outcome Measures:
Incidence of Postoperative Nausea and Vomiting (PONV) [Time Frame: Up to 72 hours] Severity of Abdominal Distension [Time Frame: Up to 72 hours]
Quality of Recovery-15 (QoR-15) Scale Score [Time Frame: Postoperative Days 1 and 3]
Gastrointestinal Symptom Rating Scale (GSRS) Score [Time Frame: Postoperative Days 1 and 3]
Eligibility Criteria:
Inclusion Criteria:
Abdominal surgery in the general surgery ward Age ≥ 18 years BMI between 18.50-24.99 kg/m² Able to communicate verbally Conscious, oriented, and willing to participate
Exclusion Criteria:
Previous gastrointestinal surgery Postoperative complications History of small bowel resection, ileostomy, or colostomy History of inflammatory bowel disease, emergency surgery, neoadjuvant therapy, appendectomy Chronic opioid use Chronic constipation (≤ 2 bowel movements per week) Abdominal radiotherapy ICU admission or postoperative bleeding
Estimated Enrollment:
80 participants (40 intervention, 40 control)
Read the detailed description
This study is a randomized controlled experimental design aimed at evaluating the effect of hot water pack application to the lumbar region on gastrointestinal motility (time to first postoperative gas, first stool, and initiation of oral intake) in patients undergoing abdominal surgery. The study will be conducted in the postoperative period.
Participants
The study will include patients who undergo abdominal surgery in the general surgery ward. Participants will be randomly assigned to one of two groups:
Intervention Group (Hot Water Pack Application) Control Group (Routine Care) Interventions
Intervention Group (Hot Water Pack Application):
Procedure: A hot water pack will be applied to the lumbar region for 20 minutes, three times a day during the first 48 postoperative hours. The hot water packs will be heated to a temperature of 40-42°C.
Purpose: To assess its effect on postoperative gastrointestinal motility (e.g., first gas, first stool, initiation of oral intake).
Control Group (Routine Care):
Procedure: Participants will receive standard postoperative care, which includes usual practices for abdominal surgery recovery without hot water pack application.
- Conditions
- Abdominal Surgery
- Being tested
- Hot Water Pack Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot Water Pack ApplicationOther
A hot water pack heated to 40-42°C will be applied to the lumbar region of the patient for 20 minutes at three intervals per day during the first 48 hours post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Hot Water Pack Application | Experimental | Patients in the intervention group will receive hot water pack application to the lumbar region. After the surgery, a hot water pack (heated to 40-42°C) will be applied to the lumbar region of the patient for 20 minutes, three times a day during the first 48 postoperative hours. The goal is to assess the effect of this intervention on gastrointestinal motility, including the time to first postoperative gas, first stool, and initiation of oral intake. Receives: Other: Hot Water Pack Application |
| Routine Care | No intervention | Patients in the control group will receive routine postoperative care as per standard clinical practices. This group will not receive hot water pack application, and will instead undergo the usual procedures followed in the postoperative period to support recovery after abdominal surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel motility
Gastrointestinal Symptom Rating Scale (GSRS) - Scale Scores The Gastrointestinal Symptom Rating Scale (GSRS) is a validated tool used to assess the severity of gastrointestinal (GI) symptoms. It consists of 15 items, each scored on a 7-point Likert scale (1 = no discomfort, 7 = severe discomfort).
Scoring Interpretation:
Total Score Range: 15 to 105 (higher scores indicate worse GI symptoms). Mean score calculation: Total score is divided by the number of items (15) to determine the severity of symptoms.
GSRS Subdimensions:
The GSRS evaluates five symptom clusters:
Reflux (2 items) → Heartburn, regurgitation Abdominal pain (3 items) → Stomach pain, hunger pain, nausea Indigestion (4 items) → Bloating, burping, early satiety, stomach rumbling Diarrhea (3 items) → Loose stools, urgency, frequency Constipation (3 items) → Hard stools, straining, incomplete evacuation
Interpretation of Scores:
15 - 30 → Mild symptoms 31 - 60 → Moderate symptoms 61 - 105 → Severe symptoms
Measured: postoperative 1-3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Responsible party
- Principal investigator, Dilek Talhaoglu, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892782
- Sponsor's protocol ID
- hot pack in abdominal surgery
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hot Pack Application on Gastrointestinal Motility After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06892782
- Acronym / sponsor ID
- hot pack in abdominal surgery
- Conditions
- Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 25 Mar 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.
Study Title:
The Effect of Hot Water Pack Application to the Lumbar Region on Gastrointestinal Motility in Postoperative Abdominal Surgery Patients
Study Type:
Interventional (Randomized Controlled Trial)
Study Design:
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blind (Outcome Assessor) Primary Purpose: Supportive Care
Condition:
Postoperative Gastrointestinal Motility in Abdominal Surgery Patients
Interventions:
Experimental: Hot Water Pack Application Intervention: Application of a hot water pack (heated to 40-42°C) to the lumbar region for 20 minutes, three times a day, in the first 48 postoperative hours.
Purpose: To evaluate its effect on gastrointestinal motility and postoperative recovery.
Control: Routine Care Intervention: Standard postoperative care without hot water pack application.
Primary Outcome Measures:
Time to First Postoperative Gas (Hours) [Time Frame: Up to 72 hours]
Time to First Postoperative Stool (Hours) [Time Frame: Up to 72 hours] Time to Initiation of Oral Intake (Hours) [Time Frame: Up to 72 hours]
Secondary Outcome Measures:
Incidence of Postoperative Nausea and Vomiting (PONV) [Time Frame: Up to 72 hours] Severity of Abdominal Distension [Time Frame: Up to 72 hours]
Quality of Recovery-15 (QoR-15) Scale Score [Time Frame: Postoperative Days 1 and 3]
Gastrointestinal Symptom Rating Scale (GSRS) Score [Time Frame: Postoperative Days 1 and 3]
Eligibility Criteria:
Inclusion Criteria:
Abdominal surgery in the general surgery ward Age ≥ 18 years BMI between 18.50-24.99 kg/m² Able to communicate verbally Conscious, oriented, and willing to participate
Exclusion Criteria:
Previous gastrointestinal surgery Postoperative complications History of small bowel resection, ileostomy, or colostomy History of inflammatory bowel disease, emergency surgery, neoadjuvant therapy, appendectomy Chronic opioid use Chronic constipation (≤ 2 bowel movements per week) Abdominal radiotherapy ICU admission or postoperative bleeding
Estimated Enrollment:
80 participants (40 intervention, 40 control)
Detailed description
This study is a randomized controlled experimental design aimed at evaluating the effect of hot water pack application to the lumbar region on gastrointestinal motility (time to first postoperative gas, first stool, and initiation of oral intake) in patients undergoing abdominal surgery. The study will be conducted in the postoperative period.
Participants
The study will include patients who undergo abdominal surgery in the general surgery ward. Participants will be randomly assigned to one of two groups:
Intervention Group (Hot Water Pack Application) Control Group (Routine Care) Interventions
Intervention Group (Hot Water Pack Application):
Procedure: A hot water pack will be applied to the lumbar region for 20 minutes, three times a day during the first 48 postoperative hours. The hot water packs will be heated to a temperature of 40-42°C.
Purpose: To assess its effect on postoperative gastrointestinal motility (e.g., first gas, first stool, initiation of oral intake).
Control Group (Routine Care):
Procedure: Participants will receive standard postoperative care, which includes usual practices for abdominal surgery recovery without hot water pack application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot Water Pack Application | Experimental | Other: Hot Water Pack ApplicationPatients in the intervention group will receive hot water pack application to the lumbar region. After the surgery, a hot water pack (heated to 40-42°C) will be applied to the lumbar region of the patient for 20 minutes, three times a day during the first 48 postoperative hours. The goal is to assess the effect of this intervention on gastrointestinal motility, including the time to first postoperative gas, first stool, and initiation of oral intake. |
| Routine Care | No intervention | –Patients in the control group will receive routine postoperative care as per standard clinical practices. This group will not receive hot water pack application, and will instead undergo the usual procedures followed in the postoperative period to support recovery after abdominal surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Undergoing elective surgery
- ASA I and III (American Society of Anesthesiologists physical status classification)
- In the postoperative period, pulse, blood pressure, and body temperature within normal limits
- Patients without previous gastrointestinal system surgery
Key exclusion criteria (8 listed)
- Previous gastrointestinal tract surgery
- Complications in the postoperative period
- History of small bowel resection and ileostomy or colostomy
- History of inflammatory bowel diseases, emergency surgery, neoadjuvant therapy, appendectomy surgery
- Chronic opioid use
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 |
|---|---|---|
| Hot Water Pack ApplicationA hot water pack heated to 40-42°C will be applied to the lumbar region of the patient for 20 minutes at three intervals per day during the first 48 hours post-surgery. | Other | Hot Water Pack Application |
Primary outcome
bowel motility
Time frame: postoperative 1-3 day
Gastrointestinal Symptom Rating Scale (GSRS) - Scale Scores The Gastrointestinal Symptom Rating Scale (GSRS) is a validated tool used to assess the severity of gastrointestinal (GI) symptoms. It consists of 15 items, each scored on a 7-point Likert scale (1 = no discomfort, 7 = severe discomfort). Scoring Interpretation: Total Score Range: 15 to 105 (higher scores indicate worse GI symptoms). Mean score calculation: Total score is divided by the number of items (15) to determine the severity of symptoms. GSRS Subdimensions: The GSRS evaluates five symptom clusters: Reflux (2 items) → Heartburn, regurgitation Abdominal pain (3 items) → Stomach pain, hunger pain, nausea Indigestion (4 items) → Bloating, burping, early satiety, stomach rumbling Diarrhea (3 items) → Loose stools, urgency, frequency Constipation (3 items) → Hard stools, straining, incomplete evacuation Interpretation of Scores: 15 - 30 → Mild symptoms 31 - 60 → Moderate symptoms 61 - 105 → Severe symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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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.
Gülseren Maraş Baydoğan contact
Questions about this trial
What is this clinical trial studying?
A study testing Hot Water Pack Application in people with Abdominal Surgery, run by TC Erciyes University.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek TALHAOĞLU, assistant professor (+905545911691, dilektalhaoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel motility (time frame: postoperative 1-3 day). 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 25 Mar 2025.