Effect of oxytocin nasal spray pretreatment on postoperative acute stress disorder in patients with accidental traumatic fracture: a single-centre prospective randomised controlled clinical trial study protocol

What Was Tested

The paper reports a study of Oxytocin, published as a clinical study.

Patients undergoing surgical procedures are often prone to developing acute stress disorder (ASD) postoperatively.

However, there are few reports on the use of oxytocin nasal spray in postoperative ASD, a condition that can potentially develop into a high-risk factor for post-traumatic stress disorder.

Who Took Part

According to the abstract, 328 patients were involved.

The age groups tagged for this paper are adults, both men and women.

The trial aims to recruit 328 patients with accidental traumatic fractures who underwent surgical treatment.

Secondary outcomes include patient resilience, anxiety, depression and pain scores on postoperative days 1-3.

How the Study Was Run

The researchers set it up as a randomized and double-blind study.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the patients and researchers unaware of who received Oxytocin.

This study is a single-centre, double-blind, randomised controlled clinical trial.

The primary outcome is the incidence of ASD on postoperative days 1-3.

The exploratory results include the concentrations of stress response indicators such as malondialdehyde, cortisol and superoxide dismutase in the saliva before the first intervention and on days 1-3 after surgery.

What Was Measured

Topics PubMed links to this paper include Oxytocin, Nasal Sprays, Postoperative Complications, Fractures, Bone, Randomized Controlled Trials as Topic and Stress Disorders, Traumatic, Acute.

The authors tagged it with the keywords Anaesthesia in orthopaedics, Clinical Trial and Psychological Stress.

What This Means in Plain Language

The paper is a randomized and double-blind study of Oxytocin in 328 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2025 (BMJ open), a journal based in England.

More context: the Oxytocin compound page, all human trials.