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IRCT20240627062264N1 IRCT 2024-07-09 Mashhad University of Medical Sciences The effect of honey on bedsores Investigating the effect of honey on the treatment of patients with bedsores grade 1 and 2 2024-09-20 anticipated 40 Complete https://irct.ir/trial/77683 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: To ensure a fair distribution of patients between control and treatment groups, we will use the stratified randomization method. In this method, patients are first classified into four groups based on age: 18-40 years, 40-60 years, 60-80 years, and over 80 years. Randomization Unit: The unit of randomization is individual (individual randomization), which means that each patient is individually assigned to one of the control or treatment groups. Randomization layers: Patients are classified into four age strata to ensure that the age distribution in both groups is balanced: 8-40 years, 40-60 years, 60-80 years, and over 80 years. Randomization Tool: [random.org] (https://www.random.org/) site is used to generate the random sequence. This site generates random numbers that will be used to assign patients to groups. How to make a random sequence First, patients are divided into four age groups based on age: the number of patients in each age group is determined to maintain the balance between age groups in both control and treatment groups. To determine the group of each patient (control or treatment), random.org is used. This site generates random numbers. The generated random numbers are assigned to the patients in order. For each random number, it is determined whether the patient will be assigned to the control or treatment group. This is done completely randomly to ensure a fair distribution of patients between the groups, Blinding description: allocation concealment: To conceal allocation and avoid bias, a blind method will be used: - Patients: Patients will not be informed of their group allocation (control or treatment) to reduce the effect of psychological bias. - The researcher analyzing the data: the researcher who analyzes the data will not be aware of the allocation of groups. This is done by coding the data in such a way that the identity of the groups is not known. This method ensures that the effect of bias in the randomization process and data analysis is minimized. N/A Bedsore. Intervention 1: Intervention group: Add 25 ml of honey to the size of 10x10 from the dressing used by bed sore patientsIn this group, unsterilized honey will be used in order to check the effectiveness of honey in healing bedsores. The intervention method is as follows: - Dressing: For each patient, 25 ml of unsterilized honey is placed on a dressing with dimensions of 10 x 10 cm. The dressings are changed carefully and the wounds are washed with normal saline.- Duration of intervention: dressing with honey is used for two weeks or until the wound heals. The process of healing or non-healing of wounds is checked using the PUSH (Pressure Ulcer Scale for Healing) questionnaire. Control group: In this group, in order to compare with the intervention group and to check the effects of honey, normal dressing will be used. The control method is as follows:- Dressing: For each patient, a normal dressing (vaseline gauze) without honey is used. The wounds are carefully washed with normal saline and the dressings are changed.- Duration of control: The normal dressing is used for two weeks or until the wound heals. The process of healing or non-healing of wounds is checked using the PUSH (Pressure Ulcer Scale for Healing) questionnaire. and will be evaluated. This questionnaire contains three categories of information:1. Depth and size of the wound2. The amount of wound secretion3. The type of tissue in the woundEach of these categories has specific subtypes that are graded based on them. Total scores are calculated from 0 (complete improvement) to 17 (most severe condition). Comparing scores over time shows whether the wound is improving or worsening. Intervention 2: Control group: In this group, in order to compare with the intervention group and to investigate the effects of honey, normal dressing will be used. The control method is as follows:- Dressing: For each patient, a normal dressing (Vaseline gauze) without honey is used. The wounds are carefully washed with normal saline and the dressings are changed. - Duration of control: The usual dressing is used for two weeks or until the wound heals. The process of healing or non-healing of wounds is checked using the PUSH (Pressure Ulcer Scale for Healing) questionnaire. How to check the healing of wounds and the healing or non-healing of wounds in both groups will be investigated and evaluated using the PUSH (Pressure Ulcer Scale for Healing) questionnaire. This questionnaire contains three categories of information: 1 depth and size of the wound 2. The amount of wound secretion 3. The type of tissue in the wound, each of these categories has specific subtypes that are scored based on them. Total scores are calculated from 0 (complete improvement) to 17 (most severe condition). Comparing scores over time indicates whether the ulcer is improving or worsening:. No - There is not a plan to make this available Justification or reason for not sharing IPD is 1. Preservation of the privacy of the participants: In order to preserve the privacy of the participants in the study, it is necessary not to publish their personal data. 2. Data security: As a fundamental principle, it is vital to protect the sensitive data of participants from unauthorized access and misuse. 3. Compliance with legal agreements: Research studies may have agreements with participants that prohibit the publication of individual data, and we must adhere to these agreements.
public Forouzan Amerizadeh
Qarani St. 12
Mashhad Iran (Islamic Republic of) 9184796137 +98 51 3729 9728 amerizadehf4011@mums.ac.ir Mashhad University of Medical Sciences scientific Forouzan Amerizadeh
Qarani St. 12
Mashhad Iran (Islamic Republic of) 9184796137 +98 51 3729 9728 amerizadehf4011@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) People with bedsores grade 1 and 2 have been confirmed for these people Patients are hospitalized 18 years no limit Both People's lack of consent to participate in this study Age less than 18 years Allergy to honey Kidney failure patients Patients taking corticosteroids L89 Pressure ulcer Diagnosis Diagnosis Intervention group: Add 25 ml of honey to the size of 10x10 from the dressing used by bed sore patientsIn this group, unsterilized honey will be used in order to check the effectiveness of honey in healing bedsores. The intervention method is as follows: - Dressing: For each patient, 25 ml of unsterilized honey is placed on a dressing with dimensions of 10 x 10 cm. The dressings are changed carefully and the wounds are washed with normal saline.- Duration of intervention: dressing with honey is used for two weeks or until the wound heals. The process of healing or non-healing of wounds is checked using the PUSH (Pressure Ulcer Scale for Healing) questionnaire. Control group: In this group, in order to compare with the intervention group and to check the effects of honey, normal dressing will be used. The control method is as follows:- Dressing: For each patient, a normal dressing (vaseline gauze) without honey is used. The wounds are carefully washed with normal saline and the dressings are changed.- Duration of control: The normal dressing is used for two weeks or until the wound heals. The process of healing or non-healing of wounds is checked using the PUSH (Pressure Ulcer Scale for Healing) questionnaire. and will be evaluated. This questionnaire contains three categories of information:1. Depth and size of the wound2. The amount of wound secretion3. The type of tissue in the woundEach of these categories has specific subtypes that are graded based on them. Total scores are calculated from 0 (complete improvement) to 17 (most severe condition). Comparing scores over time shows whether the wound is improving or worsening. Control group: In this group, in order to compare with the intervention group and to investigate the effects of honey, normal dressing will be used. The control method is as follows:- Dressing: For each patient, a normal dressing (Vaseline gauze) without honey is used. The wounds are carefully washed with normal saline and the dressings are changed. - Duration of control: The usual dressing is used for two weeks or until the wound heals. The process of healing or non-healing of wounds is checked using the PUSH (Pressure Ulcer Scale for Healing) questionnaire. How to check the healing of wounds and the healing or non-healing of wounds in both groups will be investigated and evaluated using the PUSH (Pressure Ulcer Scale for Healing) questionnaire. This questionnaire contains three categories of information: 1 depth and size of the wound 2. The amount of wound secretion 3. The type of tissue in the wound, each of these categories has specific subtypes that are scored based on them. Total scores are calculated from 0 (complete improvement) to 17 (most severe condition). Comparing scores over time indicates whether the ulcer is improving or worsening: Our outcome is bed sore healing, which will be evaluated based on the PUSH questionnaire. Timepoint: Characteristics of bedsores - measurement at the beginning of the study (day 0, before the start of the intervention) - measurement on days 3, 5, 8, 10, 12 - final measurement at the end of the study (day 15). Outcome 2: Laboratory parameters - measurement at the beginning of the study (day 0, before the start of the intervention) - final measurement at the end of the study (day 15). Method of measurement: PUSH questionnaire. Laboratory parameters - such as creatinine, C-reactive protein, alanine. Timepoint: Measurement at the beginning of the study (day 0, before the start of the intervention) - Final measurement at the end of the study (day 15). Method of measurement: By taking blood and checking with valid laboratory kits and automatic devices. Mashhad University of Medical Sciences Approved 2024-03-09 Ethics Committee of Mashhad University of Medical Sciences Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)