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Completed

NCT Number: NCT07254182

Hand Cooling With Ice Packs in Healthy Young Men

This randomized, parallel-group study looked at how a standard 15-minute ice pack applied to the back of the hand affects skin temperature and how cold and comfortable the hand feels, compared with a room-temperature water pack. Healthy young men were randomly assigned to one of the two groups during a single laboratory visit. Skin temperature was measured before, during, and after the application, and participants rated their thermal sensation (how cold/warm they felt) and overall comfort.

The main outcome was the change in hand skin temperature right after the 15-minute application. Additional outcomes included comfort and cold-feeling ratings and how quickly skin temperature returned toward baseline during recovery. This was a minimal-risk study; expected short-term effects included temporary cold, numbness, redness, or mild discomfort. No medicines or invasive procedures were used.

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Key information

Conditions

Cold Exposure Body Temperature Regulation Thermal Comfort Perception

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Physical Education, Department of Physical Therapy and Sports Recovery

Poznan, 61-871, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers (university student population).
  • Good general health with no history of neck or upper-quadrant pain.
  • Able to provide written informed consent.
  • Willing to comply with pre-visit restrictions on the study day (abstain from tobacco, coffee, alcohol; no hand ointments for 24 h; wash/degrease hands ≥1 h before testing; refrain from vigorous exercise/physical treatments for 24 h).

Exclusion criteria

  • Diabetes
  • Thyroid or other endocrine dysfunction
  • Significant spinal pain
  • Generalised neurological or rheumatological disorders
  • Regular use of pain medications or psychotropic medications

Treatment and study plan

Ice Pack (Localized Cryotherapy)

Other

Single 15-minute application of a reusable plastic Mueller ice bag (Ø 22.86 cm, 946 mL). The bag was filled with 400 g pre-portioned cylindrical ice and placed on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers. Participants were supine with the treated hand slightly elevated; ambient temperature and humidity were controlled (≈22.5 ± 1.0 °C; 55.3 ± 6.5% RH). Subjective thermal sensation/comfort (and pain) were recorded at minutes 7 and 15 during application. Arm: Experimental - Ice Pack

Thermoneutral Water Pack (Control)

Other

Identical 15-minute application using the same Mueller bag, filled with thermoneutral water (within ±0.5 °C of limb skin temperature), mass-matched to 400 g. Placement, posture, room conditions, and timing of subjective assessments (minutes 7 and 15) mirrored the experimental arm: bag on the dorsal side of the dominant hand, ~1 cm proximal to the wrist-joint line, fully covering the fingers; participants supine with the hand slightly elevated. Arm: Active Comparator - Thermoneutral Water Pack.

Primary outcomes

  1. Minimum dorsal-hand skin temperature during rewarming (IV-X), by infrared thermography

    Time frame: From immediately after pack removal (0 minutes; time point IV) to 30 minutes after pack removal (time point X).

    Region-of-interest (ROI) mean skin temperature (Tsk; °C) on the dorsal hand measured with infrared thermography (IRT; FLIR SC640). The primary estimand is the between-group mean difference (Ice - Thermoneutral) in the nadir (minimum) across rewarming time points IV-X, with 95% confidence intervals (CI). Lower values indicate greater cooling.

Secondary outcomes

  1. IRT-RT temperature offset at matched time points I-X

    Time frame: Baseline (after acclimatisation) and at 0, 5, 10, 15, 20, 25, and 30 minutes after ice-pack removal.

    Difference between infrared-thermography-derived skin temperature (TskIRT) and resistance temperature detector-derived skin temperature (TskRT), in degrees Celsius (°C), at each matched time point (I-X). IRT values represent ROI averages; resistance temperature (RT) values are point skin temperature readings from a RTD placed between the 3rd and 4th metacarpal bones. Positive values indicate that TskIRT is greater than TskRT. Between-group comparisons across time.

  2. Change in Mechanical Detection Threshold (MDT) from baseline to immediately post (I → IV)

    Time frame: Baseline (after acclimatisation; time point I) and 0 minutes after ice-pack removal (time point IV).

    MDT (g) via Semmes-Weinstein monofilaments using an up-down procedure; analysed as IV - I. Higher values indicate reduced tactile sensitivity.

  3. Change in Vibration Detection Threshold (VDT) from baseline to immediately post (I → IV)

    Time frame: Baseline (after acclimatisation; time point I) and 0 minutes after ice-pack removal (time point IV).

    VDT using a 64-Hz Rydel-Seiffer tuning fork (0-8/8 scale); analysed as IV - I. Higher values indicate reduced vibration sensitivity.

  4. Thermal Sensation (TSS) during cooling and immediately post

    Time frame: Baseline (after acclimatisation; time point I), 7 minutes after ice-pack application (time point II), 15 minutes after ice-pack application (time point III), and 0 minutes after ice-pack removal (time point IV).

    9-point TSS (-4 very cold … +4 very hot) at I-IV; peak during cooling prespecified as the maximum at II or III. Between-group comparison of peak and trajectory.

  5. Thermal Comfort (CS) during cooling and immediately post

    Time frame: Baseline (after acclimatisation; time point I), 7 minutes after ice-pack application (time point II), 15 minutes after ice-pack application (time point III), and 0 minutes after ice-pack removal (time point IV).

    5-point comfort scale (1 comfortable … 5 extremely uncomfortable) at I-IV; peak during cooling prespecified as the maximum at II or III.

  6. Pain Intensity (Visual Analogue Scale; VAS) during cooling and immediately after ice-pack removal

    Time frame: Baseline (after acclimatisation; time point I), 7 minutes after ice-pack application (time point II), 15 minutes after ice-pack application (time point III), and 0 minutes after ice-pack removal (time point IV).

    0-100 mm visual analogue scale; peak during cooling prespecified as the maximum at II or III.

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Official study title

Effects of Ice-Pack Application on Hand Skin Temperature and Subjective Thermal Sensation and Comfort in Healthy Young Men: A Randomized, Parallel-Group Controlled Trial

Acronym: ICEHAND

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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