Clinical trial NCT05750186: The Effect of Abdominal Massage Applied After Surgery
Official title: The Effect of Abdominal Massage Applied After Surgery on Gastrointestinal Symptoms and Comfort Level
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reflux, Gastroesophageal
Abdominal Pain
Constipation
Diarrhea
Dyspepsia
Keywords: Abdominal Massage
Postoperative Care
Nonpharmacological Methods
Independent Nursing Practices
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is carried out by research assistant Semiha Kurt under the supervision of Associate Professor Nuray TURAN.

In this research aimed to examine the effect of abdominal massage applied after surgical ıntervention on gastrointestinal symptoms and comfort level. The type of this study designed as randomized controlled experimental. The research hypotheses are as follows; H1: Abdominal massage applied after surgery reduces the gastrointestinal symptoms of patients.

H2: Abdominal massage applied after surgery increases the comfort level of patients.

The population of the research will consist patients who were hospitalized and underwent surgical intervention between January 2023 and July 2024 in the Orthopedics and Traumatology Clinic of the Istanbul Medical Faculty Hospital in Istanbul.The sample of the research will consist patients who cannot defecate for 3 days after surgery and who meet other sample selection criteria.

As a result of the power analysis (G\*Power 3.0.10); at least 34 samples found to be sufficient for each group with f=0.20 effect size, 90% power and 5% margin of error (n1:34, n2:34). The number of samples determined as 68 (including the experimental and control groups).

Data will be collected through the Patient Information Form, Bristol Stool Scale, Gastrointestinal Symptom Rating Scale, General Comfort Scale, and Functional Independence Scale. The patient information form was prepared by the researchers in line with the literature. Permission was obtained from the scale owners for the scales to be used in the study.

In the implementation phase of the research; in the formation of the experimental and control groups, the assignment of the patients to the experimental and control groups will be provided by randomization in the computer. Abdominal massage will be applied to the patients in the experimental group twice a day, in the morning and evening, for 3 days. Each abdominal massage will be applied for 15 minutes. The routine practice of the clinic will continue in the patients in the control group.

Institutional permission from Istanbul Medical Faculty and ethics committee approval (Number: E-74555795-050.01.04-412448) from Istanbul University-Cerrahpasa Non-Interventional Research Ethics Committee obtained in order to conduct the study. Statistical analysis of research data will be done using a package program called SPSS (IBM SPSS Statistics 24). The expenses of the research will be covered by the researcher.

Detailed description: Gastrointestinal symptoms that cause discomfort in patients and reduce their quality of life and comfort include disorders related to the esophagus, stomach, duodenum, jejunum, ileum, large intestine, sigmoid colon and rectum. These symptoms: reflux, abdominal pain, constipation, diarrhea and indigestion. After surgery, slowing of gastrointestinal system motility and change in eating habits can cause serious problems in patients by causing the development of gastrointestinal symptoms such as post-operative nausea, vomiting and hiccups. The development of these symptoms, on the other hand, prolongs the hospital discharge time of patients and may lead to increased costs. Prolonged persistence of abdominal distension after surgery; It may cause delayed wound healing due to increased pressure in the incision area, deep vein thrombosis in the legs due to decreased venous return, paralytic ileus and gastric dilation due to decreased blood flow in the intestine.Constipation; It can cause pain, nausea, vomiting, distention, feeding intolerance and contribute to the development of intestinal obstruction or perforation if not treated. There are many care and treatment methods, including pharmacological and non-pharmacological, stimulating gastrointestinal motility after surgical intervention. Abdominal massage, which is one of the non-pharmacological methods, is an important intervention in the management of gastrointestinal symptoms. Abdominal massage is a noninvasive application that stimulates bowel movements by applying patting, kneading and vibration movements over the abdominal wall to the area where the intestines are located. It increases peristalsis, creates a mechanical and reflex effect on the intestines, reducing the individual's feeling of pain and discomfort. The aim in the management of gastrointestinal symptoms is to prevent problems that may develop and to increase the quality of life and comfort of the patient by reducing these problems when they occur. Nurses are one of the team members who can diagnose and communicate with all aspects of healthy/sick individuals and their families, and take an active role in the management of gastrointestinal symptoms that may develop after surgical intervention and in the care of the individual. In this context, nurses have important roles and responsibilities. When the literature is examined, it has been observed that patients experience various problems related to gastrointestinal symptoms after surgical intervention. Abdominal massage, which is one of the non-pharmacological methods, is one of the most important independent nursing interventions in the management of gastrointestinal symptoms, as it is low cost and effective, without side effects for healthy/sick individuals and their families. In this context, this study planned to determine the effect of abdominal massage applied to patients after surgical intervention on gastrointestinal symptoms and comfort level.

In this research aimed to examine the effect of abdominal massage applied after surgical ıntervention on gastrointestinal symptoms and comfort level. The type of this study designed as randomized controlled experimental. The research hypotheses are as follows; H1: Abdominal massage applied after surgery reduces the gastrointestinal symptoms of patients.

H2: Abdominal massage applied after surgery increases the comfort level of patients.

The independent variables of the study the application of abdominal massage, the individual and disease characteristics of the patients; dependent variables are gastrointestinal symptom and comfort level scores.

The research will be carried out in the Orthopedics and Traumatology Clinic of Istanbul Medical Faculty Hospital in Istanbul between January 2023 and July 2024.

The population of the research will consist patients who were hospitalized and underwent surgical intervention between January 2023 and July 2024 in the Orthopedics and Traumatology Clinic of the Istanbul Medical Faculty Hospital in Istanbul.The sample of the research will consist patients who cannot defecate for 3 days after surgery and who meet other sample selection criteria.

Data will be collected through the Patient Information Form, Bristol Stool Scale, Gastrointestinal Symptom Rating Scale, General Comfort Scale, and Functional Independence Scale. The patient information form was prepared by the researchers in line with the literature. Permission was obtained from the scale owners for the scales to be used in the study.

Patient Information Form: It was created by the researcher based on the literature. It consists of two parts, individual and disease characteristics of the patients. In the first part; In the second part, individual characteristics such as age, gender, Body Mass Index (BMI), marital status, education level, health insurance, income level, history of surgical intervention, type of surgery and anesthesia applied, toilet habits, gastrointestinal problems, diet, nutrition habits and exercise status, first gas and stool removal time, initiation of oral intake and mobilization status. In the last part of the form, there is a table in which the bowel sounds measured during the patient follow-up will be recorded.

Bristol Stool Scale: The Bristol stool scale will be used to evaluate the individual's first stool.

Forms of feces found on the scale; Type 1 - Goat dung-like, lumpy and chunky hard stool Type 2 - Larger and combined agglomeration Type 3 - Less thick, softer stool with shallow cracks on the surface Type 4 - Stool with a smooth, slippery surface and a soft consistency Type 5 - Pieces of excrement with a consistency to give an edge Type 6 - Soft viscous, more water content, piecemeal stool Type 7 - Hard or soft, watery stool with no solid stool content Gastrointestinal Symptom Rating Scale: It was developed by Revicki et al in 1998 to evaluate common symptoms of gastrointestinal diseases, clinical experience, and views on gastrointestinal symptoms. The scale includes 15 items, each scored on a seven-point Likert-type scale, with values ranging from "no discomfort" to "very severe discomfort". 15 items based on factor analysis; It is divided into five subscales as abdominal pain, reflux, diarrhea, indigestion and constipation. How the individual feels in terms of gastrointestinal problems in the last week is questioned. Higher scores on the scale indicate more severe symptoms. He states that the Cronbach α value in the original scale was between 0.61 and 0.83. In the Turkish adaptation of the scale, the Cronbach Alpha value for all items was found to be 0.82.

General Comfort Scale: It was developed by Kolcaba in 1992 to determine comfort needs and to evaluate the situation of achieving the expected increase in comfort with nursing interventions that provide comfort. The Turkish validity and reliability study of the scale was performed by Kuğuoğlu and Karabacak in 2008. The scale is of a four-point Likert type and contains a total of 48 items. It consists of 3 levels and 4 dimensions. Scale sub-dimensions; relief (16 items), relaxation (17 items) and overcoming problems (15 items). In addition, it is related to physical comfort (12 items), psycho-spiritual comfort (13 items), environmental comfort (13 items) and socio-cultural comfort (10 items). The lowest score that can be obtained from the scale is 48, the median score is 120, and the highest score is 192. As the score obtained from the scale increases, the level of comfort perceived by the patient increases. The original Cronbach Alpha value of the scale was 0.88. In the Turkish adaptation of the scale, the Cronbach Alpha value was found to be 0.83 for all items.

Functional Independence Scale: It is an assessment tool used to evaluate the functional status of individuals. It is divided into two areas: motor and cognitive. It consists of a total of 18 items, 13 in the motor domain and 5 in the cognitive domain. 6 categories and a total of 18 activities are evaluated: self-care (42 points), sphincter control (14 points), transfer (21 points), movement (14 points), communication (14 points) and social perception (21 points). Scale scores range from 18 to 126. A seven point scale is used for each activity. FIM is divided into two measures. Motor FIM consists of 13 functional activities and cognitive FIM consists of 5 cognitive activities. If the total FIM score is 36 points or less, it is defined as high, between 37-72 points as moderate, and 73 points and above as low disability.

Application of Research Patients who meet the sample selection criteria for the study will be informed about the purpose, content and method of the study. This scope of work; Patients who do not defecate in the first 3 days after the surgical intervention will form the experimental and control groups and will be followed by the researcher for 3 days. Experimental and control groups will be determined randomly in patients undergoing surgery who meet the sample selection criteria for the study.

Experimental group

* At the first encounter with the patient; Patient Information Form, Gastrointestinal Symptom Rating Scale, General Comfort Scale and Functional Independence Scale will be applied.
* From the morning of the first day, abdominal massage will be applied to the patients 2 times a day, in the morning and in the evening, for 3 days. Each abdominal massage will be applied for 15 minutes.
* While applying abdominal massage to the patients in the experimental group, the abdominal massage application guidelines (Uysal, Eşer and Akpınar, 2012) in the literature will be used. After each massage application, the patient's bowel sounds/movements will be listened to.
* Medicines such as laxatives, suppositories and enemas will not be given to the experimental group and Bristol Stool Scale will be filled in for patients who defecate within this period.
* In order to evaluate the abdominal massage and its effect on the comfort level of the patients, the Gastrointestinal Symptom Rating Scale, General Comfort Scale and Functional Independence Scale will be applied again at the end of the 3rd day after the application of abdominal massage.

Abdominal Massage Application Guideline:

1. Hands are washed.
2. The healthy/sick individual and their relatives are informed about the procedure.
3. Pain, tenderness, tightness, redness, deterioration of skin integrity and empty bladder are evaluated in the abdominal region of a healthy/sick individual.
4. The healthy/sick individual is placed in the supine position or if there is a risky situation, the bedside of the healthy/sick individual can be 30-45 degrees above.
5. The abdominal region is opened by paying attention to the privacy of the healthy/sick individual. If the skin is damp, it is dried with a towel.
6. A small amount of liquid Vaseline is poured into the hands, and the hands are rubbed to warm the hands and spread the lotion.
7. Superficial effusion is performed by applying light pressure on the abdomen of the healthy/sick individual, starting from the upper epigastric region and downwards, over the iliac bones, from both sides of the pelvis towards the groin. With this effusion, reactive abdominal wall tension due to the first touch is prevented.
8. After the abdominal wall of the healthy/sick individual is relaxed;

   * All movements will be clockwise,
   * Considering the anatomical area starting from the right anterior superior iliac crest, from the level of the ribs to the left anterior superior iliac crest,
   * First of all, massage is applied to the right lower quadrant and right upper quadrant where the ascending colon is located, from the level of the ribs to the left upper quadrant for the transverse colon, and to the left upper and left lower quadrants for the descending colon.
   * The massage applied to each quadrant lasts at least 1 minute and moderate pressure is applied.
9. After the efflorescence movement, the same order is followed and the petrissage movement is performed with the palm.
10. Effeurage and petrissage movements are applied one after the other for 15 minutes, respectively.
11. Finally, vibration is applied using only fingertips for 1 minute and the process is terminated with effusion.
12. The healthy/sick individual is covered and given a comfortable position. Control Group

    * Patients who did not defecate within the first 3 days after surgery will constitute the control group.
    * At the first encounter with the patient; A Patient Information Form, Gastrointestinal Symptom Rating Scale (GSS), General Comfort Scale (GAS) and Functional Independence Scale (FIM) will be administered.
    * From the first encounter, patients will be given medications that are in line with their clinical routine, such as laxatives, suppositories and enemas, according to the doctor's request.
    * Intestinal sounds/movements of the patients will be listened to 6 times, 2 times a day for 3 days.
    * Bristol Stool Scale will be filled in for patients who defecate within this period.
    * At the end of the 3-day follow-up of the patients, Gastrointestinal Symptom Rating Scale, General Comfort Scale and Functional Independence Scale will be applied again and the first stool of the patients who defecate will be evaluated with the Bristol Stool Scale.

Statistical analysis of research data will be done using a package program called SPSS (IBM SPSS Statistics 24).

Institutional permission from Istanbul Medical Faculty and ethics committee approval (Number: E-74555795-050.01.04-412448) from Istanbul University-Cerrahpasa Non-Interventional Research Ethics Committee obtained in order to conduct the study. The expenses of the research will be covered by the researcher.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and above,
* Being conscious and cooperative,
* Being able to read, write and speak Turkish, not have any cognitive, sensory and spiritual problems,
* Not being pregnant,
* The vital signs are within normal limits after the surgical intervention,
* Failure to defecate for the first 3 days after the surgical intervention,
* Not using pharmacological and non-pharmacological agents with laxative effect after the surgical intervention,
* Continuing inpatient care and treatment in the orthopedics and traumatology clinic for at least 6 days,
* His willingness and volunteering to participate in the study was included.

Exclusion Criteria:

* Be less than 18 years old,
* Not knowing how to read, write and speak Turkish,
* Having any cognitive, sensory and spiritual problems,
* Presence of conditions that prevent the application of abdominal massage (hernia, bowel cancer, history of abdominal surgery and Myocardial Infarction (MI), presence of ileostomy or colostomy and bleeding, etc.),
* Being pregnant
* The vital signs are not within normal limits after the surgical intervention,
* Defecation in the first 3 days after the surgical intervention and using any pharmacological or non-pharmacological agent with laxative effect in this process, Continuing inpatient care and treatment in the orthopedics and traumatology clinic for less than 6 days,
* Not willing to participate in the study.

Primary outcomes:
measure: Gastrointestinal Symptom Rating Scale
timeFrame: Change in gastrointestinal symptoms at 6 days
measure: General Comfort Scale
timeFrame: Change in comfort level in 6 days
Secondary outcomes:
measure: Functional Independence Scale
timeFrame: Baseline
measure: Bristol Stool Scale
timeFrame: Up to 6 days after surgery
measure: Patient Information
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
References:
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