Clinical trial NCT06040411: The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting
Official title: The Effect of Acupressure on Preoperative Anxiety and Postoperative Pain and Nausea-Vomiting in ENT Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Pain
Vomiting
Nausea
Keywords: pain
ENT patients
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted in the ENT Clinic of Mersin Şehir Training and Research Hospital between June 1 and December 1, 2021, with a total of 60 adult patients, 30 in the study group and 30 in the control group, who met the inclusion and exclusion criteria.

Detailed description: In the study, 60 patients were randomly assigned to the study and control groups. The study group (n = 30) included Shen Men, the 7th acupuncture point (HT7) of the heart meridian located between the ulna and pisiform bones on the radial side of the flexor carpi ulnaris tendon, EX-HN3 (Yintang) located in the middle of the beginning of both eyebrows and the thumb and the LI4 points located in the space between the index finger (between the 1st and 2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial side) were applied for an average of 15 minutes. No intervention didn't made to the control group (n = 30). The primary outcome of the study is the effect of acupressure on the state and trait anxiety level of patients. The secondary outcome of the study is the effect of acupressure on pain and nausea and vomiting level in patients. Anxiety levels of the patients were evaluated before and 15 minutes after acupressure application; pain levels were evaluated at the 4th postoperative hour, before going to bed at night (22.00), waking up in the morning (08.00) and at discharge; nausea and vomiting levels were evaluated in the first 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Emergency ENT surgery,
* Refused to participate in the research,
* Did not sign the Informed Consent Form,
* Have a physical problem that prevents the application of acupressure to EX-HN3 (Yintang), LI4 and HT7 points,
* Diagnosed with anxiety, panic attacks and taking medication for anxiety,
* Previous surgical experience,
* Under 18 and over 65,
* People with vision, hearing and perception problems,
* unable to read and write Turkish,
* Have any problem that prevents them from communicating cognitively, emotionally and verbally,
* Experience in acupressure,
* Patients who have received sedative medication before surgical intervention didn't be included in the study.

Exclusion Criteria:

* Emergency ENT surgery,
* Refused to participate in the research,
* Did not sign the Informed Consent Form,
* Diagnosed with anxiety, panic attacks and taking medication for anxiety,
* Previous surgical experience
* Under 18 and over 65,
* People with vision, hearing and perception problems,
* unable to read and write Turkish,
* Have any problem that prevents them from communicating cognitively, emotionally and verbally,
* Experience in acupressure,
* Patients who have received sedative medication before surgical intervention didn't be included in the study.

Primary outcomes:
measure: Anxiety evaluated using the State Anxiety Scale
timeFrame: Change from before implementation and immediately after, 15th minutes after implementation
Secondary outcomes:
measure: Numerical Pain Scale
timeFrame: Change from the 4th hour after surgery, through the discharge, an average of 2 days
measure: Nausea and vomiting
timeFrame: Change from surgery to the first 24 hours
Other outcomes:
Locations:
city: Yeni̇şehi̇r
country: Turkey
facility: Tuğba ÇAM YANIK
state: Mersin
Study officials:
affiliation: Mersin University
name: Gülay ALTUN UĞRAŞ, PhD
role: STUDY_DIRECTOR
affiliation: Necmettin Erbakan University
name: Serpil YÜKSEL, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Bahar TAŞDELEN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin City Hospital
name: Seda TÜRKİLİ, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin City Hospital
name: Serkan TÜRKİLİ, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Ahmet KARAMAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: