Prevention of Constipation in Cancer Patients
ConditionConstipation Drug Induced
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarmara University
About this trial
Constipation is the third most common symptom in patients undergoing chemotherapy, with an incidence rate ranging from 31% to 90%. Despite its high prevalence and adverse effects on patients, constipation is often not reported by patients and is not frequently monitored by nurses, resulting in delays in treatment and care. Prolonged constipation can lead to health problems such as fecal impaction/obstruction, hemorrhoids, rectal pain, and intestinal perforation, thereby reducing patients' quality of life. Additionally, increased severity of constipation in cancer patients may lead to the interruption or complete cessation of chemotherapy. Therefore, it is essential to monitor and assess patients for the risk of developing constipation and to implement an effective nursing care protocol.
Abdominal massage is an approach that increases peristalsis, i.e., digestive system movement, by altering intra-abdominal pressure, thereby reducing the severity of constipation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older,
Receiving chemotherapy for breast cancer or lung cancer that causes constipation
Patients who received at least one cycle of chemotherapy and experienced chemotherapy-associated constipation within five days of treatment (stool type 1 or 2 according to the Bristol Stool Scale)
Volunteers who are willing to participate in the research, can communicate, and can read and write,
Disqualifiers
Patients with stool type 3, 4, 5, 6 and 7 points according to the Bristol Stool Scale
Trial design
Design model
Parallel
Treatments tested in this trial
Abdominal Massage
Other interventionAbdominal massage is a massage technique performed with soft and rhythmic movements applied to the abdomen. Abdominal massage is an inexpensive, non-invasive, non-harmful, non-invasive method that can be applied by nurses for the treatment of constipation or by teaching the patient and his/her family. During the application of abdominal massage, effleurage (patting), abdominal effleurage , petrissage (kneading), abdominal petrissage maneuvers are applied.
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: Abdominal Massage GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Patient Identification Form
This form was created by the researcher by reviewing the literature. The form included a total of 39 questions about the patient's current disease, descriptive characteristics, socio-demographic characteristics, chemotherapy cycle and regimen, medication use that may cause constipation, performance status score, appetite status, amount of fluid consumed daily, physical activity status, and food group consumed in the last week.
Time frame
one day2
Bristol Fecal Consistency Scale
The Bristol Stool Consistency Scale was developed by Lewis et al. The form of the stool varies according to the transit time through the intestine. With this scale, the stool form is evaluated over seven different stool types. In the scale, 1 and 2 points are evaluated as "hard stool-constipation", 3, 4 and 5 points as "normal stool", 6 and 7 points as "soft-watery stool (diarrhea)".
Time frame
five days3
Constipation Severity Scale
The Constipation Severity Scale (CSS) was developed by Varma et al. in 2008. Its Turkish validity and reliability was performed by Kaya. The scale consists of 16 items to determine the frequency and intensity of defecation and difficulty/difficulty during defecation. The scale has 3 sub-dimensions: "fecal obstruction", "laziness of the large intestine" and "pain". The score that can be obtained from the fecal obstruction sub-dimension is between 0-28, the score that can be obtained from the large intestine sub-dimension is between 0-29, and the score that can be obtained from the pain sub-dimension is between 0-16. The lowest total score that can be obtained from the scale is 0 and the highest score is 73. A high score on the scale indicates that the symptoms are serious. Cronbach's alpha value of the original scale: 0.88-0.91; Cronbach's alpha of the Turkish scale: 0.92-0.93.
Time frame
two days4
Constipation Quality of Life Scale
The scale, which was developed by Marquis et al. (2005), and validated and reliably analyzed in Turkish (2015), consists of a total of 28 items. This five-point Likert scale consists of 4 sections: 'Anxiety or Worry' (11 items), 'Physical Discomfort' (4 items), 'Psychosocial Discomfort' (8 items) and 'Satisfaction' (5 items). In the Constipation Quality of Life Scale, questions 18, 25, 26, 27 and 28 are reverse items and are calculated by reversing them. A minimum score of 28 and a maximum score of 140 is obtained from this scale. The Cronbach's alpha value of the scale is 0.96. A low total score indicates a high quality of life.
Time frame
two daysSponsors and contacts
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Marmara University
Lead sponsor
Istanbul University - Cerrahpasa
Collaborator
Source ClinicalTrials.gov