NCT07114328

Brief Summary

This study was conducted to investigate the effects of hand massage applied before needle insertion into the port catheter on anxiety and vital signs in cancer patients with port catheters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

July 24, 2025

Last Update Submit

August 3, 2025

Conditions

Chemotherapy Effect

Keywords

AnxietyHand massagePort CatheterVital Signs

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    State Trait Anxiety Inventory - STAI: The total score from the scale ranges from 20 to 80, with higher scores indicating higher anxiety levels and lower scores indicating lower anxiety levels.

    • Before the hand massage on day 1 • The hand massage on day 1, immediately after the port catheter needle is inserted • After the end of chemotherapy on day 1

Study Arms (2)

hand massage

EXPERIMENTAL

The hand massage was applied to both hands for 5-6 minutes, for a total of 10-12 minutes

Other: hand massage

control

NO INTERVENTION

no intervention

Interventions

hand massageOTHER

The hand massage was applied to both hands for 5-6 minutes, for a total of 10-12 minutes

hand massage

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who agreed to participate in the study
  • Received treatment in the Outpatient Chemotherapy Unit

You may not qualify if:

  • Who had a wound, deformity, or lesion on the hand
  • Who had inflammation, or a lesion, or similar, at the implantable venous port catheter site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mersin University

Mersin, Mersin, 33110, Turkey (Türkiye)

Location

Mersin University

Mersin, Yenişehir, 33110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Birgül VURAL DOĞRU

    Mersin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 24, 2025

First Posted

August 11, 2025

Study Start

March 15, 2023

Primary Completion

July 30, 2023

Study Completion

August 30, 2023

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)