IRCT | Comparison of the effect of two methods of family visits and acupressure on nausea and vomiting and some physiological indicators after laparoscopic cholecystectomy in the post-anesthesia care unit.

Protocol summary

Study aim: Comparison of the effect of two methods of family visits and acupressure on nausea and vomiting and physiological indicators of patients after laparoscopic cholecystectomy in the post-anesthesia care unit in Al-Zahra Hospital in Isfahan in 1999-98.
Design: Clinical trial with control group, with parallel, single blind groups, randomized to 105 patients. The website (sealedenvelope.com) was used to randomize.
Settings and conduct: This study is performed in the elective operating room of Al-Zahra Hospital in Isfahan.For the first group, acupressure is applied in two points by the researcher . In the second group, a family member comes to the patient's bedside in the recovery unit and calms the patient by touching and talking. In the third group, no intervention is applied by the researcher and the care is routinely performed. In order to perform blinding in this study, information is collected by a research colleague, and blindness is also performed in data analysis.
Participants/Inclusion and exclusion criteria: Patients who are candidates for elective laparoscopic cholecystectomy, Conscious patients, aged 65-18, with no history of mental, cardiovascular, hypertension, or gastrointestinal illnesses who do not experience nausea or vomiting before surgery.
Intervention groups: In the acupressure group, pressure will be applied on each of the P6 and LI4 points with the thumb for 2 to 5 minutes, 10 seconds of pressure is applied and 2 seconds of rest is given to the extent that the person in that point Feeling a slight pain, tingling and numbness. In the group with family visitation, the visitor should be present for 7 to 10 minutes on the patient's bedside, touching the patient's head, face, and hands, and comforting him or her by saying kind words. In the control group, routine care of the recovery department is performed.
Main outcome variables: Physiological indicators; nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200411047017N1

Registration date: 2020-07-19, 1399/04/29

Registration timing: registered_while_recruiting

Last update: 2020-07-19, 1399/04/29

Update count: 0
Registration date: 2020-07-19, 1399/04/29

Registrant information: Name

Fateme Zeraatpishe

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 71 4333 6306

Email address

zeraatpishe@nm.mui.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2020-06-06, 1399/03/17
Expected recruitment end date: 2020-09-21, 1399/06/31
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the effect of two methods of family visits and acupressure on nausea and vomiting and some physiological indicators after laparoscopic cholecystectomy in the post-anesthesia care unit.

Public title: Comparison of the effect of two methods of family visits and acupressure on nausea and vomiting and some physiological indicators after laparoscopic cholecystectomy in the post-anesthesia care unit
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Patients who are candidates for laparoscopic cholecystectomy Patients who are alert and aware of time and place Patients with age 18-65

Exclusion criteria:

Patients who are candidate for emergency cholecystectomy laparoscopic Patients with a history of mental illness Patients with a specific digestive problem that leads to nausea and vomiting Patients with cardiovascular disease and hyperytension
Age: From 18 years old to 65 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 105

Randomization (investigator's opinion)

Randomized

Randomization description

In order to create a balance in the number of samples allocated to each of the studied group, block randomization method will be used and the size of each block will be 3. A reputable website (https://www.sealedenvelope.com/simple-randomiser/v1/lists) is used to randomly assign random blocks, then the samples are placed in each of the intervention or control groups.

Blinding (investigator's opinion)

Single blinded

Blinding description

In order to perform blindness in this study, information will be collected by a research colleague who, to ensure the correct performance of the colleague, the information for 5 patients is randomly recorded by the researcher and research colleague and then compared with each other. Blindness will also be considered for data analysis.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Isfahan University of Medical Sciences

Street address

Isfahan-Hezar Jerib St.-Isfahan University of Medical Sciences

City

Isfahan

Province

Isfehan

Postal code

81746-73461
Approval date: 2020-04-20, 1399/02/01
Ethics committee reference number: IR.MUI.RESEARCH.REC.1399.027

Health conditions studied

1

Description of health condition studied: cholecystitis
ICD-10 code: K80.0
ICD-10 code description: Calculus of gallbladder with acute cholecystitis

2

Description of health condition studied: postoperative nausea and vomiting
ICD-10 code: R11
ICD-10 code description: Nausea and vomiting

Primary outcomes

1

Description: Average of blood pressure
Timepoint: Before induction of anesthesia, after the intervention, up to 12 hours in the surgical unit
Method of measurement: Monitoring system

2

Description: Average oxygen saturation of arterial blood
Timepoint: Before induction of anesthesia, after the intervention, up to 12 hours in the surgical unit
Method of measurement: pulse oximeter probe

3

Description: The average number of heartbeats
Timepoint: Before induction of anesthesia, after the intervention, up to 12 hours in the surgical unit
Method of measurement: Monitoring system

4

Description: The average number of breaths
Timepoint: Before induction of anesthesia, after the intervention, up to 12 hours in the surgical unit
Method of measurement: Monitoring system

5

Description: Average of patients pain intensity
Timepoint: Before and after the intervention
Method of measurement: Visual Analogue Scale

6

Description: The average of vomiting number, severity and extent
Timepoint: Before induction of anesthesia, before leaving recovery, up to 12 hours in the surgical unit
Method of measurement: Rhodes questionnaire

7

Description: The average score of the number, duration and severity of nausea
Timepoint: Before induction of anesthesia, before leaving recovery, up to 12 hours in the surgical unit
Method of measurement: Rhodes questionnaire and Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description: Intervention Group 1, which visits the family, explains to the patient that after surgery and in recovery, a first-degree relative will be present at his or her bedside and asked to express the name of a person who feels most comfortable with him or her . The visitor is then assessed separately and their abilities to participate in the study are assessed. People under the age of 18 and those who are scared and anxious when they see monitors and equipment next to the patient are not suitable to participate in the study. After confirming the accompanying ability to participate in the study, the etiquette of meeting in recovery is explained to them. If the researcher finds that the patient does not understand the explanation with the questions and answers while teaching, the sample will be removed from the study. This training will be face-to-face and will be done by the researcher and the companion will be asked to control their nerves, give all their focus to their patient, face the patient with a determined spirit, Touch his head, face or hands and comfort him. Then, visitor enters recovery after put on the surgical gown and shoes and washing his hands. In order to protect the privacy of other patients, partitions around the sample's bed will be placed. The visitor will stay with the patient for 7 to 10 minutes with the permission of the person in charge of the recovery department. This intervention will be done in addition to routine recovery care, including warming the patient, oxygen therapy, fluid therapy, pain relief, vital signs check, surgical wound and drainage control, and controlling nausea and vomiting, and more. In the case of severe nausea and vomiting, patients will take medications(Ondansetron) , according to doctor's diagnosis.
Category: Other

2

Description: For the intervention group 2, which is acupressure, the researcher will be trained before the intervention under the supervision of a specialist in acupressure. Pressure will be applied to each of the P6 and LI4 points with the thumb for 2 to 5 minutes to apply pressure, so that pressure is applied for 10 seconds and stopped for 2 seconds. The intensity of the pressure would be such that one third of the thumbnails turn white and the pressure is applied rotational in a clockwise direction. The intensity of the pressure should be optimal, firm and stable, and pleasant to the point of pain. It should be high enough for the person to feel mild pain, tingling, and numbness at that point. at first the pressure apply in point P6 and then LI4 to the left hand. This intervention will be done in addition to routine recovery care. In the case of severe nausea and vomiting, patients will take medications(Ondansetron), according to doctor's diagnosis.
Category: Other

3

Description: In group 3, which is the control group, routine recovery proceedings include warming the patient, oxygen therapy, fluid therapy, pain relief, vital signs check, surgical wound and drainage control, will be done, And no intervention is done by the researcher. And to control nausea and vomiting, if patients in any of the three groups suffers from severe nausea and vomiting, medication (Ondansetron) will be taken by patients, according to doctor's diagnosis.
Category: Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Alzahra Hospital

Full name of responsible person

Akram Aarabi

Street address

Isfahan, Hezar-Jerib St, Isfahan University of Medical Sience

City

Isfahan

Province

Isfehan

Postal code

81746-73461

Phone

+98 31 3792 7510

Email

aarabi@nm.mui.ac.ir

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Akram Aarabi

Street address

Hezar-Jerib st, Isfahan University of Medical Science

City

Isfahan

Province

Isfehan

Postal code

81746-73461

Phone

+98 31 3792 7510

Email

aarabi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Esfahan University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Fateme Zeraatpishe

Position

MSc Student

Latest degree

Master

Other areas of specialty/work

Surgical Technology (opeerating room)

Street address

Hezar-Jerib St, Isfahan University of Medical Science

City

Isfahan

Province

Isfehan

Postal code

81746-73461

Phone

+98 31 3792 7510

Email

zeraatpishe@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Akram Aarabi

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nursery

Street address

Hezar-Jerib St, Isfahan University of Medical Science

City

Isfahan

Province

Isfehan

Postal code

81746-73461

Phone

+98 31 3792 7510

Email

aarabi@nm.mui.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Fateme Zeraatpishe

Position

MSc Student

Latest degree

Master

Other areas of specialty/work

Surgical Technology (operating room)

Street address

Hezar-Jerib St, Isfahan University of Medical Science

City

Isfahan

Province

Isfehan

Postal code

81746-73461

Phone

+98 31 3792 7510

Email

zeraatpishe@nm.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Comparison of the effect of two methods of family visits and acupressure on nausea and vomiting and some physiological indicators after laparoscopic cholecystectomy in the post-anesthesia care unit.