Critical Illnesspressure injurNCT07904520
Abdominal Massage and Range-of-motion Exercise in Enterally Fed ICU Patients With Pressure Injuries
A study testing LAM group and ROM in people with Critical Illness and Pressure Injuries, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Pressure Injuries, Enteral Nutrition Intolerance in Critically Ill Patients
- What is being tested?
- LAM group and ROM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 30 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Receiving enteral nutrition for at least 24 hours
- Having at least one pressure injury
- Aged 18 years or older
- Written informed consent from the patient or, if the patient is unable to consent, from a relative
Who cannot join
- History of abdominal surgery that would prevent the study interventions from being performed
- Surgical condition that restricts joint movement
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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:
- Group 1: lower abdominal massage in addition to routine care
- Group 2: ROM exercises in addition to routine care
- Control group: routine care only The interventions will be applied for 15 minutes once a day for 7 days. Digestive tolerance (bowel movements, gastric residual volume, nausea, vomiting, abdominal distension), serum albumin, and pressure injury healing (Pressure Ulcer Scale for Healing, PUSH) will be monitored daily.
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).
- Conditions
- Critical Illness, Pressure Injuries, Enteral Nutrition Intolerance in Critically Ill Patients
- Being tested
- LAM group, 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,, ROM, Control
- Keywords
- Intensive care, enteral nutrition, pressure ulcer, abdominal massage, ROM exercise, nursing intervention
- Medical subject headings
- Critical Illness, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAM groupOther
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,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, for 7-days. Gastric residual volume was assessed between 02:00-04:00 AM, when enteral feeding was paused.
ROMOther
Also called 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
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.
ControlOther
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1: LAM | Experimental | 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). Receives: 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, |
| Intervention group 2: ROM exercise | Experimental | 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. Receives: 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 |
| Control Group | Experimental | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and daily for 7 days
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: Baseline and daily for 7 days (Day 1 to Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 May 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elçin Sebahat Kasapoğlu, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904520
- Sponsor's protocol ID
- 2025-SBB-0068
- Acronym
- pressure injur
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
1. Kottner Jan, Worsley P.R, Brienza David. National Pressure Injury Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Pressure Ulcers/Injuries: Definition ad Etiology. In: Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. The International Guideline: Fourth Edition. Emily Haesler (Ed.). 2025. 2025. 2. Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020;105:103546. https://doi.org/10.1016/J.IJNURSTU.2020.103546. 3. Kıraner E, Kaya H. Pressure injuries in patients hospitalized in intensive care with the diagnosis of COVID-19 and retrospective analysis of risk factors . Yoğun Bakım Hemşireliği Dergisi. 2021;25:139-51. 4. Li J, Wang L, Zhang H, Zou T, Kang Y, He W, et al. Different definitions of feeding intolerance and their associations with outcomes of critically ill adults receiving enteral nutrition: a systematic review and meta-analysis. J Intensive Care. 2023;11:29. https://doi.org/10.1186/S40560-023-00674-3. 5. Lin-Yin W, Chia-Ming L, Lin HL, Chu-Yu C, Tzeng YS. Risk factors for recurrent pressure ulcers after reconstructive surgery: A retrospective study in a single medical centre. Int Wound J. 2023;20:2511-7. https://doi.org/10.1111/IWJ.14112. 6. Yanamaladoddi V, D'Cunha H, Charley E, Kumar V, Sohal A, Youssef W. Early enteral nutrition in critically-ill patients. World J Crit Care Med. 2025;14. https://doi.org/10.5492/WJCCM.V14.I3.102834. 7. Banks MD, Ross LJ, Webster J, Mudge A, Stankiewicz M, Dwyer K, et al. Pressure ulcer healing with an intensive nutrition intervention in an acute setting: a pilot randomised controlled trial. J Wound Care. 2016;25:384-92. https://doi.org/10.12968/JOWC.2016.25.7.384. 8. Ahmed Mohamed H, Hussein Bakr Z, Mohamed Naguib A. Effect of Abdominal Massage on Gastrointestinal Function among Enterally Fed Critically Ill Patien
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Massage and Range-of-motion Exercise in Enterally Fed ICU Patients With Pressure Injuries
- ClinicalTrials.gov ID
- NCT07904520
- Acronym / sponsor ID
- pressure injur / 2025-SBB-0068
- Conditions
- Critical Illness, Pressure Injuries, Enteral Nutrition Intolerance in Critically Ill Patients
- Keywords
- Intensive care, enteral nutrition, pressure ulcer, abdominal massage, ROM exercise, nursing intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 Oct 2026 (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 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:
- Group 1: lower abdominal massage in addition to routine care
- Group 2: ROM exercises in addition to routine care
- Control group: routine care only The interventions will be applied for 15 minutes once a day for 7 days. Digestive tolerance (bowel movements, gastric residual volume, nausea, vomiting, abdominal distension), serum albumin, and pressure injury healing (Pressure Ulcer Scale for Healing, PUSH) will be monitored daily.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1: LAM | Experimental | 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 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 group 2: ROM exercise | Experimental | 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: ROMThe 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. |
| Control Group | Experimental | Other: ControlNo 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving enteral nutrition for at least 24 hours
- Having at least one pressure injury
- Aged 18 years or older
- Written informed consent from the patient or, if the patient is unable to consent, from a relative
Key exclusion criteria (2 listed)
- History of abdominal surgery that would prevent the study interventions from being performed
- Surgical condition that restricts joint movement
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 |
|---|---|---|
| LAM groupThe 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 | Intervention group 1: LAM |
| 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,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. | Other | Intervention group 1: LAM, Intervention group 2: ROM exercise |
| ROMAlso: 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 jointThe 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 group 2: ROM exercise |
| ControlAlso: 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, monitNo 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 Group |
Primary outcome
Change in total score on the Pressure Ulcer Scale for Healing (PUSH) of the first (largest) pressure injury
Time frame: Baseline and daily for 7 days
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.
8 secondary outcomes
Change in total PUSH score of the 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
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Percentage of participants with defecation
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
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Percentage of participants with abdominal distension
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Gastric residual volume
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Serum albumin concentration
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
Enteral feeding flow rate
Time frame: Baseline and daily for 7 days (Day 1 to Day 7)
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 29 Oct 2026.
- Results publication1. Kottner Jan, Worsley P.R, Brienza David. National Pressure Injury Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Pressure Ulcers/Injuries: Definition ad Etiology. In: Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline. The International Guideline: Fourth Edition. Emily Haesler (Ed.). 2025. 2025. 2. Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020;105:103546. https://doi.org/10.1016/J.IJNURSTU.2020.103546. 3. Kıraner E, Kaya H. Pressure injuries in patients hospitalized in intensive care with the diagnosis of COVID-19 and retrospective analysis of risk factors . Yoğun Bakım Hemşireliği Dergisi. 2021;25:139-51. 4. Li J, Wang L, Zhang H, Zou T, Kang Y, He W, et al. Different definitions of feeding intolerance and their associations with outcomes of critically ill adults receiving enteral nutrition: a systematic review and meta-analysis. J Intensive Care. 2023;11:29. https://doi.org/10.1186/S40560-023-00674-3. 5. Lin-Yin W, Chia-Ming L, Lin HL, Chu-Yu C, Tzeng YS. Risk factors for recurrent pressure ulcers after reconstructive surgery: A retrospective study in a single medical centre. Int Wound J. 2023;20:2511-7. https://doi.org/10.1111/IWJ.14112. 6. Yanamaladoddi V, D'Cunha H, Charley E, Kumar V, Sohal A, Youssef W. Early enteral nutrition in critically-ill patients. World J Crit Care Med. 2025;14. https://doi.org/10.5492/WJCCM.V14.I3.102834. 7. Banks MD, Ross LJ, Webster J, Mudge A, Stankiewicz M, Dwyer K, et al. Pressure ulcer healing with an intensive nutrition intervention in an acute setting: a pilot randomised controlled trial. J Wound Care. 2016;25:384-92. https://doi.org/10.12968/JOWC.2016.25.7.384. 8. Ahmed Mohamed H, Hussein Bakr Z, Mohamed Naguib A. Effect of Abdominal Massage on Gastrointestinal Function among Enterally Fed Critically Ill Patien
- Individual participant dataSharing planned: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAM group and ROM in people with Critical Illness and Pressure Injuries, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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 29 Oct 2026. 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 Turkey (Türkiye). 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 total score on the Pressure Ulcer Scale for Healing (PUSH) of the first (largest) pressure injury (time frame: Baseline and daily for 7 days). 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 NCT07904520, which also lists 1 linked publication.
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 29 Oct 2026.