An interventional study of LAM group and Intervention and control-group data were collected daily at 10:00 AM. In the intervention groups, each 15-minute session was followed by outcome measurements the next day before the following session, in Critical Illness, Pressure Injuries and Enteral Nutrition Intolerance in Critically Ill Patients, sponsored by Bartın Unıversity. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Bartın Unıversity · Not applicable, Interventional, and Prevention
The purpose of this study is to evaluate whether two nursing interventions, lower abdominal massage and range-of-motion (ROM) exercises (gentle movements of the arm and leg joints), affect the healing of pressure injuries (bed sores) in intensive care patients who are fed through a tube (enteral nutrition).
Intensive care patients often stay in bed for long periods and are at high risk of pressure injuries. Adequate nutrition is important for wound healing, but tube-fed patients often have digestive problems such as constipation, vomiting, bloating, or food remaining in the stomach, which can interrupt feeding.
The main question this study will address is: Compared with routine care, do lower abdominal massage or ROM exercises affect digestive tolerance, nutritional markers, and pressure injury healing in tube-fed intensive care patients? The researchers hypothesize that lower abdominal massage may reduce digestive problems and support uninterrupted feeding, and that ROM exercises may support circulation and tissue healing. Both effects may, in turn, support pressure injury healing.
Adult patients who have a pressure injury and receive enteral nutrition in the intensive care units of a state hospital in Türkiye will be randomly assigned to one of three groups:
Detailed Description This is a three-arm, parallel-group, randomized controlled experimental study planned for the intensive care units of a secondary-level state hospital in Türkiye. Patients who meet the eligibility criteria will be allocated to lower abdominal massage, ROM exercise, or routine care using a computer-generated randomization list (Microsoft Excel). The sample size will be calculated with G*Power before data collection (planned minimum: 90 patients; effect size 0.20, alpha 0.05, 95% confidence level).
Interventions: Lower abdominal massage (15 minutes: superficial effleurage, palm petrissage, fingertip vibration, closing effleurage; clockwise along the colon, with hands warmed in liquid paraffin) will be performed by an intensive care nurse. ROM exercises (flexion-extension, abduction-adduction and rotation of the upper and lower limb joints, with the patient supine; 3 repetitions per movement, held 30 seconds at the point of resistance; 15 minutes in total) will be performed after the researchers receive ROM training from a physiotherapist. The control group will receive routine intensive care only (nasogastric tube position checks, monitoring of gastric residual volume, defecation, nausea and vomiting, daily Braden Scale assessment, two-hourly repositioning, and stage-appropriate topical wound care).
Data will be collected daily at 10:00 using a Patient Information Form and an Intervention/Control Group Patient Monitoring Form. Gastric residual volume will be assessed between 02:00 and 04:00 when feeding is paused.
Planned analysis: Normality will be assessed with skewness and kurtosis values (±3). Between-group comparisons will use chi-square/Fisher's exact test, one-way ANOVA or Kruskal-Wallis test with post hoc tests. Within-group changes over time will use repeated-measures ANOVA, Friedman test, or Cochran's Q test as appropriate (significance p\<0.05).
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's enrollment of 90 is above the median of 70 across 405 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Bartın Unıversity is the lead sponsor of 47 studies on the registry; 11 are open to participants now.
Compared within Pressure Ulcer, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The LAM performed by the researcher, an intensive care nurse, lasted 15 minutes, consisting of 1 minute of superficial effleurage, 10 minutes of petrissage with the palms, 3 minutes of vibration with the fingertips, and 1 minute of effleurage to conclude the massage. It was performed with hands warmed in liquid paraffin, moving clockwise (starting from the right lower quadrant and following the path of the ascending, transverse, and descending colon).
Other: LAM group · Other: Intervention and control-group data were collected daily at 10:00 AM. In the intervention groups, each 15-minute session was followed by outcome measurements the next day before the following session,
The ROM exercises included flexion-extension, abduction-adduction, and rotation movements of the shoulder, elbow, wrist, and finger joints in the upper extremity, and of the hip, knee, and ankle joints in the lower extremity, while the patient was in the supine position. Each movement was repeated 3 times and held for 30 seconds at the point of resistance, for a total of 15 minutes. The researchers received one day of ROM training from a physiotherapist before the study began.
Other: Intervention and control-group data were collected daily at 10:00 AM. In the intervention groups, each 15-minute session was followed by outcome measurements the next day before the following session, · Other: ROM
No additional interventions were performed on the patients in the control group, and the institution's routine ICU care was continued. Routine ICU care included nasogastric tube position checks, monitoring of gastric residual volume, defecation, nausea and vomiting, daily Braden Scale assessment, two-hourly repositioning, and stage-appropriate topical wound treatment.
Other: Control
The LAM performed by the researcher, an intensive care nurse, lasted 15 minutes, consisting of 1 minute of superficial effleurage, 10 minutes of petrissage with the palms, 3 minutes of vibration with the fingertips, and 1 minute of effleurage to conclude the massage. It was performed with hands warmed in liquid paraffin, moving clockwise (starting from the right lower quadrant and following the path of the ascending, transverse, and descending colon).
Intervention and control-group data were collected daily at 10:00 AM. In the intervention groups, each 15-minute session was followed by outcome measurements the next day before the following session, for 7-days. Gastric residual volume was assessed between 02:00-04:00 AM, when enteral feeding was paused.
The ROM exercises included flexion-extension, abduction-adduction, and rotation movements of the shoulder, elbow, wrist, and finger joints in the upper extremity, and of the hip, knee, and ankle joints in the lower extremity, while the patient was in the supine position. Each movement was repeated 3 times and held for 30 seconds at the point of resistance, for a total of 15 minutes. The researchers received one day of ROM training from a physiotherapist before the study began.
Also known as: The ROM exercises included flexion-extension, abduction-adduction, and rotation movements of the shoulder, elbow, wrist, and finger joints in the upper extremity, and of the hip, knee, and ankle joint
No additional interventions were performed on the patients in the control group, and the institution's routine ICU care was continued. Routine ICU care included nasogastric tube position checks, monitoring of gastric residual volume, defecation, nausea and vomiting, daily Braden Scale assessment, two-hourly repositioning, and stage-appropriate topical wound treatment.
Also known as: No additional interventions were performed on the patients in the control group, and the institution's routine ICU care was continued. Routine ICU care included nasogastric tube position checks, monit
Change in total score on the Pressure Ulcer Scale for Healing (PUSH) of the first (largest) pressure injury
Pressure injury healing will be measured with the Pressure Ulcer Scale for Healing (PUSH), version 3.0, which combines wound surface area (length × width), exudate amount and tissue type into a total score. Unit of measure: score on a scale (range 0-17; higher scores indicate a worse wound status). The change from baseline to Day 7 will be reported for the first (largest) pressure injury of each participant.
Time frame: Baseline and daily for 7 days
Change in total PUSH score of the second pressure injury
Unit of measure: score on a scale (PUSH total score, range 0-17; higher scores indicate a worse wound status). Measured with the Pressure Ulcer Scale for Healing (PUSH) in participants who have a second pressure injury.
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Change in total PUSH score of the third pressure injury
Unit of measure: score on a scale (PUSH total score, range 0-17; higher scores indicate a worse wound status). Measured with the Pressure Ulcer Scale for Healing (PUSH) in participants who have a third pressure injury.
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Percentage of participants with defecation
Unit of measure: percentage of participants who had at least one bowel movement in the preceding 24 hours, recorded daily by the researcher on the Intervention/Control Group Patient Monitoring Form (nursing observation/chart record).
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Percentage of participants with nausea or vomiting Baseline and daily for 7
Unit of measure: percentage of participants with nausea and/or vomiting episodes in the preceding 24 hours, recorded daily on the Patient Monitoring Form by nursing observation.
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Percentage of participants with abdominal distension
Unit of measure: percentage of participants with abdominal distension, assessed daily by clinical observation/palpation of the abdomen by the researcher and recorded on the Patient Monitoring Form.
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Gastric residual volume
Unit of measure: millilitres (mL). Gastric residual volume is aspirated through the nasogastric tube with a syringe between 02:00 and 04:00 when enteral feeding is paused, and recorded daily.
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Serum albumin concentration
Unit of measure: concentration in grams per litre (g/L). Serum albumin is measured by the hospital laboratory from routine venous blood samples and recorded daily from the patient file.
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Enteral feeding flow rate
Unit of measure: millilitres per hour (mL/h). The formula infusion rate is read from the enteral feeding pump/order and recorded daily. (Enteral water flow rate, also in mL/h, may be added as a separate outcome if desired.)
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Plan to share: No — Health data is classified as sensitive personal information under legal frameworks such as GDPR and HIPAA. To protect patient privacy, comply with medical ethics, and prevent potential discrimination or misuse, individual patient data cannot be shared with third parties without explicit consent or a strict legal mandate. For research or statistical purposes, data must be fully anonymized or aggregated to guarantee patient identity protection.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bartın Unıversity