Protocol summary
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Study aim
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The effect of plantar reflexology on anxiety and physiological parameters of patients undergoing extracorporeal lithotripsy is investigated
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Design
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Clinical trial with control group, with parallel groups, without blinding, randomized from available samples, phase 3 on 74 patients. Blocked randomization was used for randomization
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Settings and conduct
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Massage for patients is performed by a same-sex researcher who will undergo reflexology training. The massage is performed 10 minutes after the patients enter the bed where they are hospitalized. Which will be performed in a room in a ward where the patient's privacy is observed and environmental stimuli are minimal. The reflexology procedure in this study is based on Fitzgerald methodology by the interventionist.
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Participants/Inclusion and exclusion criteria
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Entry requirements:Age range 18 to 65 years
Perform extracorporeal lithotripsy for the first time
No obstruction at the site of pressure (wounds, skin diseases, etc.)
No entry conditions:Having previous experience or knowledge of the impact of acupressure
Drug addiction
Existence of sensory and motor disorders in the legs
Allergy to olive oil
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Intervention groups
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In the intervention group, reflexology procedures are performed based on Fitzgerald methodology. The massage of the left foot lasts for 10 minutes (for each foot) at a slow pace, with a regular rhythm . 2 minutes are for general foot massage and in the next stage, reflex points on the sole, including the diaphragm, solar plexus, pituitary gland, lungs, and adrenal glands, were massaged.. Then the same steps are performed on the patient's right foot.
In the control group, only routine care is performed.
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Main outcome variables
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Anxiety; pain ; Physiological parameters
General information
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Reason for update
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Changes in the randomization method, sample size, and duration of the trial and acupressure points that needed to be changed during the work process due to limitations
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190729044370N2
Registration date:
2022-06-18, 1401/03/28
Registration timing:
prospective
Last update:
2024-03-05, 1402/12/15
Update count:
1
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Registration date
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2022-06-18, 1401/03/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-07-02, 1401/04/11
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Expected recruitment end date
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2022-11-05, 1401/08/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of plantar reflexology on pain, anxiety and physiological parameters of patients undergoing extracorporeal lithotripsy
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Public title
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The effect of plantar reflexology on pain, anxiety and physiological parameters
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Signing the informed consent form
Age range 18 to 65 years
Perform extracorporeal lithotripsy for the first time
Lack of previous experience or knowledge of the effects of acupressure
Full consciousness, no mental, visual and auditory disorders
No history of taking anti-anxiety and sedative drugs one week before participating in the study (based on the contents of the file)
No drug addiction
Have a minimum literacy to complete the questionnaire;
No obstruction at the site of pressure (wounds, skin diseases, etc.)
Absence of sensory and motor disorders in the legs and minimal ability to walk on the legs (peripheral neuropathy or vascular problems in the lower extremities)
Lack of sensitivity to olive oil
Body mass index (BMI) between 18.5 to 30 kg/m2
Have an anxiety score of 43 or higher on the Spielberger scale
Exclusion criteria:
Failure to complete the patient procedure for any reason
unwillingness to continue the intervention
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
74
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Due to the gradual entry of samples into the research in this study, Among the available patients, patients with equal number of members are assigned to each of the intervention and control groups by a blocked randomization design .
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-05-17, 1401/02/27
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Ethics committee reference number
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IR.ARAKMU.REC.1401.044
Health conditions studied
1
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Description of health condition studied
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The effect of plantar reflexology on pain, anxiety and physiological parameters
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Anxiety: Anxiety score in Spielberger questionnaire
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Timepoint
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Anxiety measurement will be done before and one hour after the start of the intervention
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Method of measurement
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The Spielberger Anxiety Inventory will be used to assess patients' anxiety. This questionnaire includes separate self-assessment scales to measure overt and covert anxiety.
2
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Description
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Pain: Pain intensity from 0 to 10
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Timepoint
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Pain measurement will be done before and after the start of the intervention
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Method of measurement
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The numerical pain scale is numbered from 0 to 10 (0 without pain and 10 maximum pain).
3
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Description
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Physiological parameters of patients including heart rate, respiration, systolic and diastolic blood pressure.
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Timepoint
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physiological parameters measurement will be done before and after the start of the intervention
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Method of measurement
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To measure the pulse rate and oxygen saturation of arterial blood with a pulse oximeter and to measure the number of breaths, after observing a complete respiratory cycle, including inhalation and exhalation, we count the number of breaths and to measure blood pressure use a sphygmomanometer.
Intervention groups
1
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Description
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Control group: In the control group, only routine care is performed
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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80
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available