The effect of oral melatonin in reduction pain during venipuncture _a double blind clinical trial

The effect of oral melatonin in reduction pain during venipuncture in children referred to Taleghani Children's Hospit

The study will be conducted on children aged 3 to 6 who will be referred to the hospital for whom venipuncture will be performed. The children will be randomly divided into two groups A (melatonin receivers) and B group (placebo receivers). The study is double blind.

The study will be conducted in Taleghani Hospital, Gorgan, on children aged 3 to 6 who will undergo vein extraction. The children will be randomly divided into two groups: A (melatonin recipient) and B group (placebo recipient). The study is double blind

inclusion criteria : children with 3-6 y old reffered to Taleghani hospital need to venipuncture for intravenous infusion parental consent to participate in the study exclusion criteria : loss of consciousness acut and lifethreatening state any psycological disorder ( ADHD , autism) receive any sedative or pain releif drug emergency state

melatonin recipient group

Pain score

Randomization method and tool: In this study, we will use the restricted randomization method of the block randomization type. Blocking is usually used in order to create a balance in the number of samples allocated to each of the studied groups. This feature helps researchers to ensure that the number of samples allocated to each of the study groups is equal in cases where intermediate analyzes are needed during the sampling process. The total size of the blocks is equal and in this trial we will have two groups of 6 blocks including 3 participants in the intervention group and 3 participants in the control group. The randomization tool is also used from random allocation software, which, in addition to simple randomization, is capable of generating random sequences using the block method.

Concealment: We will use allocation concealment. By using opaque letter envelopes sealed with a random sequence, in this method, each of the generated random sequences is recorded on a card and the cards are placed inside the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. Double masked blind Both patients and all researchers related to patients are unaware of the patient's perceived exposure. The patient can be identified with a code that is placed in an envelope, and in another place it is clear whether this number is a medicine or a placebo.

preservation of personal information

Statistical Analysis Plan Study protocol Clinical trial report

2 months after the results are published.

Researchers working in academic and scientific institutions.

using data for a larger study using data for similar study

Dr zohre akbari jokar Zohreakbari2351@yahoo.com 09104323922

The applicant should contact me via e-mail or mobile phone number and state his request and the reason for the need for information. After consulting with the research group and the Guide master, the information will be provided to them.