CareCar_PackageNCT06399133
Care Package for Postoperative Constipation
A study testing Warm water intake, High-fiber diet and Abdominal massage in people with Care and Constipation, run by Kubra KAYA at 1 site in Turkey (Türkiye).
Trial summary
Background: Postoperative constipation is a common complication. The effectiveness of a care package constituting warm water intake, abdominal massage, and a high-fiber diet has not been investigated in patients undergoing orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Care, Constipation
- What is being tested?
- Warm water intake, High-fiber diet and Abdominal massage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 3 Apr 2023
- 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
- aged ≥ 18 years,
- undergoing elective orthopedic surgery,
- able to read and write in Turkish,
- without any psychiatric illness or reception of psychiatric medications
- without chronic constipation or reception of constipation medications
- without abdominal wounds
Show all 10Show fewer
- mobilization in the preoperative period
- without bandages or wraps on the arm and hand that would hinder answering questions
- ASA score <III,
- willing to participate in the study.
Who cannot join
- patients
- immobilized for ≥ 2 days postoperatively,
- with ileus within the first three days postoperatively,
- discharged or transferred to another service before three days postoperatively,
- unable to tolerate oral intake due to reasons such as a nasogastric tube or trauma-related jaw and mouth injuries in the postoperative period,
- who voluntarily withdrew from the study at any stage after volunteering to participate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Orthopedics and Traumatology Clinic of Abdulkadir Yüksel State Hospital in Gaziantep.
Gaziantep, Central, 27100
About this study
Background: Postoperative constipation is a common complication. The effectiveness of a care package constituting warm water intake, abdominal massage, and a high-fiber diet has not been investigated in patients undergoing orthopedic surgery.
Aim: the investigators determined the effects of a care package, including warm water intake, abdominal massage, and high-fiber diet, on constipation prevention, aiming to improve patient quality of life during the postoperative period and support nurses in clinical practice.
Study design: This was a single-center, randomized controlled trial of patients hospitalized in the Orthopedics and Traumatology Clinic of a state hospital between September 15, 2022, and April 30, 2023. Overall, 102 patients were randomly assigned to study and control groups. Routine clinical practice was maintained for patients in the control group, whereas a care package constituting postoperative warm water intake, abdominal massage, and a high-fiber diet was provided to those in the study group. Data was collected using the 'Constipation Risk Assessment Scale' and 'Visual Analog Scale'. Constipation severity was evaluated by administering the scales one day before surgery (T0) and one (T1), two (T2), three (T3), and four (T4) days postoperatively. Data were analyzed using SPSS software (version 20.0; IBM, Canada). Statistical significance was set at p < 0.05.
Read the detailed description
INTRODUCTİON Constipation is a common complication observed in patients undergoing orthopedic surgery. The incidence of constipation is reported to be between 40-72% in these patients . Factors such as immobilization during the postoperative period, opioid use, addressing voiding and bowel movements in bed, pain, and inadequate intake of food and fluids contribute to increased susceptibility to constipation in patients undergoing orthopedic surgery. Prolonged immobilization of patients undergoing orthopedic surgery and the widespread use of opioid analgesics in pain management protocols can increase the frequency of constipation. Additionally, increased catecholamine release due to surgical stress is considered a cause for decreased bowel mobility, leading to constipation during the postoperative period.
Constipation can lead to multiple adverse effects in patients, such as discomfort, bloating, pain, loss of appetite, nausea, vomiting, and increased psychosocial stress. Prevention and reduction of constipation symptoms improve patient comfort and quality of life. Constipation in surgical patients increases the risk of postoperative complications and prolongs hospital stay .
Multiple studies have utilized non-pharmacological methods to prevent constipation. The effects of abdominal massage and a high-fiber diet were investigated in studies aimed at preventing constipation in patients undergoing orthopedic surgery. However, no study has investigated the effects of early warm water intake on constipation in patients undergoing orthopedic surgery. Nevertheless, one study found that patients administered warm water postoperatively experienced earlier bowel movements.
The benefits of implementing care packages have been reported; however, the literature on care packages aimed specifically at preventing constipation remains limited. Several existing care packages have been reported to be effective in preventing constipation . However, no study investigated the effects of a triple care package constituting early postoperative warm water intake, abdominal massage, and a high-fiber diet on constipation prevention in patients undergoing orthopedic surgery, and previous studies have focused on individual components of the investigated care package.
AIMS AND HYPOTHESİS We aimed to determine the effects of a three-intervention constipation prevention care package constituting early postoperative warm water intake, abdominal massage, and a high-fiber diet on the severity of postoperative constipation in patients undergoing orthopedic surgery. We aimed to improve patients' quality of life and to support nurses in clinical practice during the postoperative period. Our study contributes to the literature owing to the lack of studies that investigated the effects of the aforementioned care package on constipation prevention in patients undergoing orthopedic surgery.
The following hypotheses were tested in this study:
H11: The constipation prevention care package shortens the time to first defecation postoperatively in patients undergoing orthopedic surgery.
H12: The constipation prevention care package reduces postoperative constipation severity in patients undergoing orthopedic surgery.
- Conditions
- Care, Constipation
- Being tested
- Warm water intake, High-fiber diet, Abdominal massage
- Keywords
- Constipation Risk, Constipation Severity, Nursing, Care, Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm water intakeOther
Nurses assessed the patients' gag and swallow reflexes in the SG. Patients who experienced nausea after reflex assessment were considered to have positive reflexes and were administered warm water. Packaged water was boiled in a kettle and poured into 200 mL disposable cups. After cooling the water to 38-40°C using a thermometer, patients were instructed to drink it within 3 min.
High-fiber dietOther
After initiating oral intake, the patients collaborated with a dietitian to incorporate high-fiber foods containing 30 g of fiber daily into their meal menus.
Abdominal massageOther
Patients in the SG received abdominal massages twice a day, in the morning from 08:00 to 09:00 and in the evening from 19:00 to 20:00, for 15 min per session, starting one day postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in the CG received routine postoperative clinical interventions. |
| Study Group | Experimental | Patients in the SG received a care package including warm water intake, abdominal massage, and a high-fiber diet. Receives: Other: Warm water intake; Other: High-fiber diet; Other: Abdominal massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Demographic Characteristics Form:
The first section included questions about the patient's sex, marital status, date of birth, education level, presence of a companion, employment status, presence of chronic diseases, use of continuous medications, type of surgery, general dietary habits, place of residence, bowel habits before surgery, and regular exercise habits. This form was administered to the patients one day before surgery.
Measured: up to 4 weeks
Part 2: Constipation Risk Assessment Scale
This scale, developed by Richmond and Wright, has been tested for reliability and validity in Turkish by Koca et al. (2011) [18,19]. The original version of the scale had a Cronbach's alpha value of 0.50; however, it was determined to be 0.43 in the Turkish version [18,19]. Written permission to use the scale was obtained from Koca Kutlu et al. The scale constituted four sections, and scores were assigned at the end of each section. The total score was the sum of the section scores. The score range was 0-63, with higher scores indicating a higher risk of constipation[18]. Individuals scoring ≤10 were classified into the low-risk group, those scoring 11-15 into the moderate-risk group, and those scoring ≥ 16 into the high-risk group. This form was administered to the patients one day before surgery.
Measured: up to 4 weeks
Part 3: Visual Analog Scale (VAS):
): The VAS was first used by Pamuk et al. (2003) to determine symptoms related to constipation [20]. Symptoms such as straining, incomplete bowel emptying, constipation, pressure sensation in the rectum, severity of gas formation, and pain in the rectum were measured using the VAS. Low scores indicated mild symptoms, whereas high scores indicated severe symptoms. The VAS was administered to patients one day before surgery (T0) and one (T1), two (T2), three (T3), and four (T4) days postoperatively.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Jan 2023
- Primary completion27 Feb 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CareStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This was a single-center, randomized controlled trial of patients hospitalized in the Orthopedics and Traumatology Clinic of a state hospital between September 15, 2022, and April 30, 2023. Overall, 102 patients were randomly assigned to study and control groups. Routine clinical practice was maintained for patients in the control group, whereas a care package constituting postoperative warm water intake, abdominal massage, and a high-fiber diet was provided to those in the study group. Data was collected using the 'Constipation Risk Assessment Scale' and 'Visual Analog Scale'. Constipation severity was evaluated by administering the scales one day before surgery (T0) and one (T1), two (T2), three (T3), and four (T4) days postoperatively. Data were analyzed using SPSS software (version 20.0; IBM, Canada). Statistical significance was set at p \< 0.05.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubra KAYA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kubra KAYA, Hasan Kalyoncu University
- Investigators
- Kübra KAYA, PhD, Study director, kubra.kaya@hku.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399133
- Sponsor's protocol ID
- kübra_1
- Acronym
- Car_Package
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Package for Postoperative Constipation
- ClinicalTrials.gov ID
- NCT06399133
- Acronym / sponsor ID
- Car_Package / kübra_1
- Conditions
- Care, Constipation
- Keywords
- Constipation Risk, Constipation Severity, Nursing, Care, Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Kubra KAYAUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 3 May 2024 (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.
Background: Postoperative constipation is a common complication. The effectiveness of a care package constituting warm water intake, abdominal massage, and a high-fiber diet has not been investigated in patients undergoing orthopedic surgery.
Aim: the investigators determined the effects of a care package, including warm water intake, abdominal massage, and high-fiber diet, on constipation prevention, aiming to improve patient quality of life during the postoperative period and support nurses in clinical practice.
Study design: This was a single-center, randomized controlled trial of patients hospitalized in the Orthopedics and Traumatology Clinic of a state hospital between September 15, 2022, and April 30, 2023. Overall, 102 patients were randomly assigned to study and control groups. Routine clinical practice was maintained for patients in the control group, whereas a care package constituting postoperative warm water intake, abdominal massage, and a high-fiber diet was provided to those in the study group. Data was collected using the 'Constipation Risk Assessment Scale' and 'Visual Analog Scale'. Constipation severity was evaluated by administering the scales one day before surgery (T0) and one (T1), two (T2), three (T3), and four (T4) days postoperatively. Data were analyzed using SPSS software (version 20.0; IBM, Canada). Statistical significance was set at p < 0.05.
Detailed description
INTRODUCTİON Constipation is a common complication observed in patients undergoing orthopedic surgery. The incidence of constipation is reported to be between 40-72% in these patients . Factors such as immobilization during the postoperative period, opioid use, addressing voiding and bowel movements in bed, pain, and inadequate intake of food and fluids contribute to increased susceptibility to constipation in patients undergoing orthopedic surgery. Prolonged immobilization of patients undergoing orthopedic surgery and the widespread use of opioid analgesics in pain management protocols can increase the frequency of constipation. Additionally, increased catecholamine release due to surgical stress is considered a cause for decreased bowel mobility, leading to constipation during the postoperative period.
Constipation can lead to multiple adverse effects in patients, such as discomfort, bloating, pain, loss of appetite, nausea, vomiting, and increased psychosocial stress. Prevention and reduction of constipation symptoms improve patient comfort and quality of life. Constipation in surgical patients increases the risk of postoperative complications and prolongs hospital stay .
Multiple studies have utilized non-pharmacological methods to prevent constipation. The effects of abdominal massage and a high-fiber diet were investigated in studies aimed at preventing constipation in patients undergoing orthopedic surgery. However, no study has investigated the effects of early warm water intake on constipation in patients undergoing orthopedic surgery. Nevertheless, one study found that patients administered warm water postoperatively experienced earlier bowel movements.
The benefits of implementing care packages have been reported; however, the literature on care packages aimed specifically at preventing constipation remains limited. Several existing care packages have been reported to be effective in preventing constipation . However, no study investigated the effects of a triple care package constituting early postoperative warm water intake, abdominal massage, and a high-fiber diet on constipation prevention in patients undergoing orthopedic surgery, and previous studies have focused on individual components of the investigated care package.
AIMS AND HYPOTHESİS We aimed to determine the effects of a three-intervention constipation prevention care package constituting early postoperative warm water intake, abdominal massage, and a high-fiber diet on the severity of postoperative constipation in patients undergoing orthopedic surgery. We aimed to improve patients' quality of life and to support nurses in clinical practice during the postoperative period. Our study contributes to the literature owing to the lack of studies that investigated the effects of the aforementioned care package on constipation prevention in patients undergoing orthopedic surgery.
The following hypotheses were tested in this study:
H11: The constipation prevention care package shortens the time to first defecation postoperatively in patients undergoing orthopedic surgery.
H12: The constipation prevention care package reduces postoperative constipation severity in patients undergoing orthopedic surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a single-center, randomized controlled trial of patients hospitalized in the Orthopedics and Traumatology Clinic of a state hospital between September 15, 2022, and April 30, 2023. Overall, 102 patients were randomly assigned to study and control groups. Routine clinical practice was maintained for patients in the control group, whereas a care package constituting postoperative warm water intake, abdominal massage, and a high-fiber diet was provided to those in the study group. Data was collected using the 'Constipation Risk Assessment Scale' and 'Visual Analog Scale'. Constipation severity was evaluated by administering the scales one day before surgery (T0) and one (T1), two (T2), three (T3), and four (T4) days postoperatively. Data were analyzed using SPSS software (version 20.0; IBM, Canada). Statistical significance was set at p < 0.05.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in the CG received routine postoperative clinical interventions. |
| Study Group | Experimental | Other: Warm water intake, Other: High-fiber diet, Other: Abdominal massagePatients in the SG received a care package including warm water intake, abdominal massage, and a high-fiber diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- aged ≥ 18 years,
- undergoing elective orthopedic surgery,
- able to read and write in Turkish,
- without any psychiatric illness or reception of psychiatric medications
- without chronic constipation or reception of constipation medications
Key exclusion criteria (6 listed)
- patients
- immobilized for ≥ 2 days postoperatively,
- with ileus within the first three days postoperatively,
- discharged or transferred to another service before three days postoperatively,
- unable to tolerate oral intake due to reasons such as a nasogastric tube or trauma-related jaw and mouth injuries in the postoperative period,
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 |
|---|---|---|
| Warm water intakeNurses assessed the patients' gag and swallow reflexes in the SG. Patients who experienced nausea after reflex assessment were considered to have positive reflexes and were administered warm water. Packaged water was boiled in a kettle and poured into 200 mL disposable cups. After cooling the water to 38-40°C using a thermometer, patients were instructed to drink it within 3 min. | Other | Study Group |
| High-fiber dietAfter initiating oral intake, the patients collaborated with a dietitian to incorporate high-fiber foods containing 30 g of fiber daily into their meal menus. | Other | Study Group |
| Abdominal massagePatients in the SG received abdominal massages twice a day, in the morning from 08:00 to 09:00 and in the evening from 19:00 to 20:00, for 15 min per session, starting one day postoperatively. | Other | Study Group |
Primary outcome
Part 1: Demographic Characteristics Form:
Time frame: up to 4 weeks
The first section included questions about the patient's sex, marital status, date of birth, education level, presence of a companion, employment status, presence of chronic diseases, use of continuous medications, type of surgery, general dietary habits, place of residence, bowel habits before surgery, and regular exercise habits. This form was administered to the patients one day before surgery.
Part 2: Constipation Risk Assessment Scale
Time frame: up to 4 weeks
This scale, developed by Richmond and Wright, has been tested for reliability and validity in Turkish by Koca et al. (2011) [18,19]. The original version of the scale had a Cronbach's alpha value of 0.50; however, it was determined to be 0.43 in the Turkish version [18,19]. Written permission to use the scale was obtained from Koca Kutlu et al. The scale constituted four sections, and scores were assigned at the end of each section. The total score was the sum of the section scores. The score range was 0-63, with higher scores indicating a higher risk of constipation[18]. Individuals scoring ≤10 were classified into the low-risk group, those scoring 11-15 into the moderate-risk group, and those scoring ≥ 16 into the high-risk group. This form was administered to the patients one day before surgery.
Part 3: Visual Analog Scale (VAS):
Time frame: up to 4 weeks
): The VAS was first used by Pamuk et al. (2003) to determine symptoms related to constipation [20]. Symptoms such as straining, incomplete bowel emptying, constipation, pressure sensation in the rectum, severity of gas formation, and pain in the rectum were measured using the VAS. Low scores indicated mild symptoms, whereas high scores indicated severe symptoms. The VAS was administered to patients one day before surgery (T0) and one (T1), two (T2), three (T3), and four (T4) days postoperatively.
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 3 May 2024.
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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.
Kübra KAYA, PhD study director
kubra.kaya@hku.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm water intake, High-fiber diet and Abdominal massage in people with Care and Constipation, run by Kubra KAYA 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 10 inclusion and 6 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 3 May 2024. 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?
Part 1: Demographic Characteristics Form: (time frame: up to 4 weeks). 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?
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 3 May 2024.