The Effect of Classical Hand Massage, Lavender Inhalation and Hand Massage With Lavender on Anxiety, Pain and Comfort

NCT06949293 | Active Not Recruiting

• 1 other identifier: E-10840098-202.3.02-3033
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Cystoscopy is one of the most commonly performed urologic procedures to examine the anatomy and evaluate pathologies of the lower urinary tract. Although cystoscopy is a safe procedure with a low risk of morbidity, it can often cause pain, anxiety and restlessness in patients. This study aims to determine the effects of classical hand massage, lavender inhalation and lavender hand massage applied to patients undergoing cystoscopy on the patient's anxiety, pain and comfort. The population of the study will consist of patients who underwent cystoscopy between July 2024 and April 2025. Data will be obtained with the Patient Identification Form, Vital Signs Follow-up Form, State Anxiety Scale, Numerical Pain Scale and Numerical Comfort Scale. The research will be conducted in three stages: before, during and after the cystoscopy procedure. In the pre-cystoscopy period, patients who meet the study inclusion criteria will be informed about the procedure and verbal and written permissions will be obtained. Randomization will be performed according to the order of application and the patients will be divided into four groups as the classical hand massage group, the lavender inhalation group, the lavender hand massage group and the control group. The Patient Identification Form will be filled in and the scales will be introduced. The vital signs of the patients in the intervention groups will be assessed half an hour before the procedure and the State Anxiety Scale will be filled in. In addition, a ten-minute application will be performed before the procedure and their vital signs and the State Anxiety Scale will be assessed five minutes after the procedure. During the cystoscopy period, after the patients in the intervention group are taken to the cystoscopy table and lidocaine gel is applied, their vital signs and pain levels will be assessed during the passage of the cystoscopy instrument from the urethra to the bladder. A ten-minute application will be performed during the procedure in the intervention groups and their vital signs and pain will be assessed immediately after the cystoscopy is completed. In the post-procedure period, half an hour after the cystoscopy procedure, the vital signs of the patients will be measured again, and the Numerical Pain Scale and Numerical Comfort Scale will be filled. The same data will be collected from the patients in the control group without any application.

Conditions

Cystoscopy; Aromatherapy; Hand Massage

Keywords

Aromatherapy; Pain; Anxiety; Hand Massage; Comfort; Cystoscopy

Outcome Measures

Primary Outcomes (7)

• participants' level of anxiety

  State Anxiety Scale:The scale developed by Spielberg et al. in 1964 to measure the state anxiety levels of normal and abnormal individuals was adapted into Turkish by Öner and Le Compte (1983). It is a self-assessment type scale consisting of short statements. It was developed to measure a person's anxiety at a particular moment. The state anxiety scale, which consists of 20 items, is a scale that determines how an individual feels at a particular moment and condition. The emotions or behaviors expressed in the items of the SCS are answered by marking one of the options according to the degree of intensity (1) not at all, (2) a little, (3) a lot, (4) completely. There are 10 reversed statements in the inventory. These statements are items 1,2,5,8,10,11,15,16,19 and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of the direct and inverted statements. The scores obtained in the state anxiety scale theoretically vary betw

  Perioperative

• participants' level of pain

  Numeric Pain Scale: This scale, which is intended to determine the severity of pain, aims to explain the patient's pain with numbers. The "0-10" numerical pain scale was used to assess the severity of the patients' pain. On numerical scales, pain starts with absence of pain (0) and reaches up to unbearable pain (10).

  Perioperative

• Number of Participants with high comfort rate

  Numerical Comfort Scale: It is a 10 cm long, horizontally usable measurement tool for determining the comfort level, starting with "0- most uncomfortable" and ending with "10- most comfortable". A high score indicates a high comfort level

  Perioperative

• Body temperature of participants

  The researcher will be measured with a digital non-contact thermometer.

  Perioperative

• Systolic and diastollic blood pressure of participants

  The researcher will measure it using a digital blood pressure monitor.

  Perioperative

• Pulse rate of participants

  The researcher will measure it using pulse oximetry

  Perioperative

• Oxygen saturation of participants

  The researcher will measure it using pulse oximetry

  Perioperative

Study Arms (4)

Classic hand massage group

ACTIVE COMPARATOR

Patients included in the study who are planned to undergo cystoscopy will be assigned to the classical hand massage group by matching them with the randomization table according to the order of arrival. There will be 36 patients in this group.

Other: Classic hand massage

Lavender inhalation group

ACTIVE COMPARATOR

Patients included in the study who are planned to undergo cystoscopy will be assigned to the lavender inhalation group by matching them with the randomization table according to the order of arrival. There will be 36 patients in this group.

Other: Lavender inhalation

Hand massage group with lavender oil

ACTIVE COMPARATOR

The patients included in the study who are planned to undergo cystoscopy will be assigned to the hand massage group with lavender oil by matching them with the randomization table according to the order of arrival. There will be 36 patients in this group.

Other: Hand massage with lavender oil

Control group

NO INTERVENTION

This group will not receive any intervention other than routine practice. There will be 36 patients in this group.

Interventions

Hand massage with lavender oil OTHER

Each hand of the patient will be massaged with lavender oil for 5 minutes before and during cystoscopy. Before the application, 5% lavender oil will be applied to a small part of the hand and this area will be monitored for signs of allergic reaction such as swelling and redness. If no allergic reaction is observed, the study will continue.

Hand massage group with lavender oil

Classic hand massage OTHER

Each hand of the patient will be massaged with baby oil for 5 minutes before and during the cystoscopy procedure.

Classic hand massage group

Lavender inhalation OTHER

Before and during the cystoscopy procedure, 2-3 drops of 5% lavender oil will be poured onto a 5x5 cm sterile gauze. It will be placed 10 cm away from the patient's nose and sniffed for 10 minutes.

Lavender inhalation group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older,
• Being a man
• Having cystoscopy for the first time,
• Local anesthesia will be performed,
• Rigid cystoscopy will be performed,
• No obstacles to communication,
• Having a good sense of smell,
• No known history of allergy to the essential oil used,
• To agree to participate in the research

You may not qualify if:

• Having any contraindication for the procedure (urinary tract infection, lidocaine allergy, anatomical problems with the urethra, etc.),
• Having used any painkiller at least 24 hours before cystoscopy,
• Performing manipulations such as bladder biopsy, Double J catheter insertion or removal

Sponsors & Collaborators

• Afide Tufan: lead

Study Sites (1)

Kula State Hospital

Manisa, Kula, 45170, Turkey (Türkiye)

Location

Related Publications (4)

• Kwon WA, Lee JW, Seo HK, Oh TH, Park SC, Jeong HJ, Seo IY. Hand-Holding during Cystoscopy Decreases Patient Anxiety, Pain, and Dissatisfaction: A Pilot Randomized Controlled Trial. Urol Int. 2018;100(2):222-227. doi: 10.1159/000485745. Epub 2017 Dec 22.

  PMID: 29275402 BACKGROUND

• Krajewski W, Zdrojowy R, Wojciechowska J, Koscielska K, Dembowski J, Matuszewski M, Tupikowski K, Malkiewicz B, Kolodziej A. Patient comfort during flexible and rigid cystourethroscopy. Wideochir Inne Tech Maloinwazyjne. 2016;11(2):94-7. doi: 10.5114/wiitm.2016.60665. Epub 2016 Jun 17.

  PMID: 27458489 BACKGROUND

• Laszkiewicz J, Krajewski W, Luczak M, Chorbinska J, Nowak L, Bardowska K, Zdrojowy R. Pain reduction methods during transurethral cystoscopy. Contemp Oncol (Pozn). 2021;25(2):80-87. doi: 10.5114/wo.2021.106652. Epub 2021 May 28.

  PMID: 34667433 BACKGROUND

• Gezginci E, Bedir S, Ozcan C, Iyigun E. Does Watching a Relaxing Video During Cystoscopy Affect Pain and Anxiety Levels of Female Patients? A Randomized Controlled Trial. Pain Manag Nurs. 2021 Apr;22(2):214-219. doi: 10.1016/j.pmn.2020.08.005. Epub 2020 Sep 29.

  PMID: 33008780 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Selda RIZALAR, Prof. Dr.

  The University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 29, 2025
• Study Start: August 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)