An interventional study of stress ball squeezing in Postoperative Pain, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Not applicable, Interventional, and Prevention
This project aims to investigate whether the use of a stress ball during the perioperative period, as a non-invasive, drug-free, simple, and easy-to-implement intervention, can reduce the incidence of moderate-to-severe visceral pain within 24 hours after surgery in postpartum women.
Against the backdrop of persistently high cesarean section rates, postoperative pain has become an increasingly prominent issue. Pharmacological treatment is constrained by breastfeeding safety concerns, and women undergoing cesarean section, as a population susceptible to anxiety, are caught in a vicious cycle of anxiety and pain. Distraction-based interventions have shown favorable effects but have limitations. As a simple and non-invasive tool, the stress ball has been preliminarily shown in other surgeries to have the potential to relieve pain and anxiety; however, its application in the perioperative period of cesarean section remains unexplored. This study intends to conduct a randomized controlled trial to systematically evaluate the effects of squeezing a stress ball during the perioperative period of cesarean section on maternal anxiety and postoperative pain, aiming to provide a safe, economical, and easily scalable non-pharmacological adjunct intervention for enhanced recovery after cesarean section.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 208 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 102 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the pre-anesthesia room, each patient receives a sterilized, palm-sized elastic stress ball. She is instructed to squeeze it tightly for 3 s, then relax, repeating this rhythm; she may add slow breathing or silently count 1-3 and use it as needed when anxious. Intervention starts on entering the pre-anesthesia room and lasts until the end of surgery. Four standardized 5-min periods are set: (1) after entering the pre-anesthesia room and completing pre-intervention data collection; (2) after entering the operating room and before neuraxial anesthesia; (3) after anesthesia is completed and vital signs are stable until before fetal delivery; (4) after fetal delivery until before the end of surgery. The minimum cumulative intervention time is 20 min per participant. After this dose, patients may continue as needed without interfering with vital sign monitoring, anesthesia, or surgical procedures, using the same squeeze-3-s/relax-3-s rhythm.
Device: stress ball squeezing
No stress ball is provided, no additional distraction intervention is administered, and only routine departmental care is given.
In the pre-anesthesia room, give the patient a sterilized, palm-sized elastic stress ball. Instruct her to repeatedly "squeeze for 3 s, then relax," optionally with slow breathing or silently counting 1-3, and to use it as needed when anxious. The intervention begins on entry into the pre-anesthesia room and continues until the end of surgery. Four standardized periods are set: (1) after entry into the pre-anesthesia room and completion of pre-intervention data collection; (2) after entry into the operating room and before neuraxial anesthesia; (3) after anesthesia completion and vital-sign stabilization until before fetal delivery; (4) after fetal delivery until before the end of surgery. In each period, continuous intervention lasts 5 min, with a minimum cumulative intervention time of 20 min per participant. After the minimum dose, the parturient may use the stress ball as needed for anxiety or discomfort if it does not interfere with monitoring, anesthesia, or surgery.
incidence of moderate to severe visceral pain within 24 hours postoperatively
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).The NRS scores for visceral pain at rest and during activity were assessed in parturients at 6 h , 12 h , and 24 h postoperatively. Moderate-to-severe visceral pain was defined as an NRS score of ≥4 (on a 0-10 scale) at any of these time points.
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Frequency of rescue analgesic use within 24 hours postoperatively
Time frame: within 24 hours after cesarean section
The area under the curve (AUC) of NRS scores for visceral pain at rest and during activity within 24 hours postoperatively in parturients.
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity)
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Pre- and post-intervention 6-item STAI-S anxiety scores
Six-item Short-Form State-Trait Anxiety Inventory (STAI-S6): the raw sum score ranges from 6 to 24.Higher scores indicate a worse outcome (greater state anxiety).
Time frame: Pre-anesthesia , before operating room exit，at 6 hours、12 hours、and 24 hours after surgery
NRS scores for visceral pain at rest and during activity within 24 hours postoperatively (at 6 h, 12 h, and 24 h after surgery)
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Hydromorphone equivalent dose within 24 hours after surgery
Time frame: within 24 hours after cesarean section
Effective PCIA pump presses within 24 h postop.
The number of effective presses on the PCIA pump can be automatically counted by the pump's backend program.
Time frame: within 24 hours after cesarean section
score of pain sensitivity measurement
For the pressure algometer used to measure pain sensitivity, the relevant metric is the Pressure Pain Threshold (PPT). There is no universal minimum or maximum: values are device- and probe-dependent (theoretical minimum 0; e.g., 0-2000 kPa for a 1 cm² probe or 0-4000 kPa for a 0.5 cm² probe). Higher PPT scores indicate a better outcome (lower pressure pain sensitivity), whereas lower scores indicate greater pain sensitivity.
Time frame: before intervention in the pre-anesthesia room, immediately upon completion of surgery, and 24 hours postoperatively.
NRS scores for incisional pain at rest and on movement within 24 hours after surgery.
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Postoperative adverse reactions
Time frame: within 24 hours after cesarean section
AUC of incisional pain NRS scores at rest and on movement within 24 hours after surgery.
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Changes in maternal heart rate during cesarean section.
maternal heart rate (beats/min) wil be measured solely by the operating room monitor
Time frame: during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closure
Changes in maternal non-invasive blood pressure during cesarean section.
non-invasive blood pressure (systolic/diastolic, mmHg) wil be measured solely by the operating room monitor
Time frame: during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closure
Changes in maternal pulse oxygen saturation during surgery.
peripheral oxygen saturation (SpO₂, %) wil be measured solely by the operating room monitor
Time frame: during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closure
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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