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Enteral NutritionNCT06225687

Heat Application on Gastrointestinal System Functions

A study testing Heat Application in people with Enteral Nutrition and Gastrointestinal System--Abnormalities, run by TC Erciyes University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Complications related to the gastrointestinal system can occur in patients receiving enteral nutrition. These complications may include nausea, vomiting, diarrhea, constipation, decreased bowel sounds, abdominal distension, increased gastric residual volume, and abdominal pain. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Heat Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Feb 2024to 1 Dec 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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Intensive care unit patients
  • Individuals aged 18 and above
  • Patients receiving enteral nutrition via nasogastric tube
  • Patients on the first day of enteral nutrition
  • Those receiving standard enteral nutrition solution
  • Patients without wounds in the abdominal region
Show all 15Show fewer
  • Individuals who have not undergone abdominal surgery in the last 6 months
  • Patients not undergoing radiation/chemotherapy
  • Those with a high-output fistula without ileus problems
  • Patients without diarrhea and constipation
  • Patients with a Glasgow Coma Scale (GKS) > 3
  • Those with an APACHE II score > 16
  • Patients not taking prokinetic agents
  • Patients not taking laxative medications
  • Patients without any contraindications for the application of heat, such as neuropathy (to be determined in consultation with the primary doctor).

Who cannot join

  • Patients in whom enteral nutrition is discontinued during the study
  • Patients transitioning to a product other than the standard one in enteral nutrition
  • Patients who temporarily pause enteral nutrition
  • Patients who have started prokinetic agents
  • The study will be terminated in patients who have started taking laxative medications.

Trial locations and contacts

No sites are listed yet.

Özlem Ceyahn contact

+903522076666 ext. 28561

ozlemg@erciyes.edu.tr

About this study

Official title: The Effect of Heat Application on Gastrointestinal System Functions in Patients Receiving Continuous Enteral Nutrition

Complications related to the gastrointestinal system can occur in patients receiving enteral nutrition. These complications may include nausea, vomiting, diarrhea, constipation, decreased bowel sounds, abdominal distension, increased gastric residual volume, and abdominal pain. To prevent and treat food intolerance, as well as to increase gastric emptying, the use of prokinetic agents is often preferred. However, these drugs have various side effects, such as abdominal cramps, allergies, bronchospasm, cardiac issues, and pancreatic disorders. One non-pharmacological method that can be applied to increase bowel motility and reduce abdominal distension and constipation is heat application. The aim of this study is to determine the effect of heat application to the abdominal and lumbar regions, using a hot water bag, on gastrointestinal system functions in patients receiving continuous enteral nutrition.

Being tested
Heat Application
Keywords
Enteral Nutrition, Heat Application, Gastrointestinal System Functions, Continuous Enteral Nutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heat ApplicationOther

    The researcher will conduct daily measurements of gastric residual volume (GRV) and abdominal circumference, listen to bowel sounds, and assess distension from the first day of enteral nutrition initiation. Additionally, they will record the frequency of vomiting/defecation. Subsequently, a 15-minute hot application will be applied to the abdominal/lumbar region.

Study groups in NCT06225687
Study groupRoleWhat they receive
Heat ApplicationExperimentalHeat will be applied to the abdominal/lumbar area for 15 minutes.
Receives: Other: Heat Application
Control GroupNo interventionNo intervention will be made.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastric residual volume

    GRV measurement will be made 30 minutes after stopping feeding. It will be evaluated before and after application.

    Measured: 7 days

  2. Abdominal Distension

    Abdominal distension will be assessed 30 minutes after stopping feeding. The palpation method will be used. Additionally, abdominal circumference will be measured with a tape measure. Evaluation will be made before and after the intervention.

    Measured: 7 days

  3. Bowel sounds

    Bowel sounds should be evaluated 30 minutes after stopping feeding. Bowel sounds are listened to with a stethoscope for one minute. It will be evaluated before and after the intervention.

    Measured: 7 days

Secondary outcomes (2)

  1. Defecation Patterns

    measure defecation frequency and nature

    Measured: 7 days

  2. Vomiting

    The number of vomitings during the day is recorded

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06225687
Sponsor's protocol ID
HeatAppGastro
Status last verified
Jan 2024
First submitted
28 Nov 2023
Last updated
26 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dehghan M, Fatehi Poor A, Mehdipour-Rabori R, Ahmadinejad M. Effect of abdominal massage on prevention of aspiration in intubated and enterally fed patients: A randomized controlled trial. J Complement Integr Med. 2020 Sep 23;17(3). doi: 10.1515/jcim-2017-0124.

    PubMed 31710593

  • Zhang W, Zhou W, Kong Y, Li Q, Huang X, Zhao B, Su H, Chen S, Shen X, Qiu Z. The effect of abdominal massage on enteral nutrition tolerance in patients on mechanical ventilation: A Randomized Controlled Study. Intensive Crit Care Nurs. 2023 Apr;75:103371. doi: 10.1016/j.iccn.2022.103371. Epub 2022 Dec 15.

    PubMed 36528462

  • Uysal N, Eser I, Akpinar H. The effect of abdominal massage on gastric residual volume: a randomized controlled trial. Gastroenterol Nurs. 2012 Mar-Apr;35(2):117-23. doi: 10.1097/SGA.0b013e31824c235a.

    PubMed 22472671

  • Makino Y, Choe MA. Effects of Hot Packs on Small-Intestinal Motility Measured by Doppler Ultrasound and Subjective Feelings in Normal Adults. Gastroenterol Nurs. 2017 Jul/Aug;40(4):279-286. doi: 10.1097/SGA.0000000000000222.

    PubMed 28746113

Questions about this trial

What is this clinical trial studying?

A study testing Heat Application in people with Enteral Nutrition and Gastrointestinal System--Abnormalities, 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 15 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jan 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Özlem Ceyahn (+903522076666 ext. 28561, ozlemg@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric residual volume (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06225687, which also lists 4 linked publications.

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 26 Jan 2024.

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